Study Manager Resume Samples

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F Champlin

Frieda

Champlin

179 Yundt Ports

Phoenix

+1 (555) 200 4662

179 Yundt Ports

Phoenix

Phone

p +1 (555) 200 4662

Experience Experience

Dallas, TX

Study Manager

Dallas, TX

Kunze, Maggio and Pfannerstill

Dallas, TX

Study Manager

Be first and foremost focused on creating a culture of care by being a visible safety leader, engaging, developing and coaching your team
Coordinate study activities to maximise value by lowering operating cost, optimising schedules and implementing prudent capital plans
Coordinate the application of project engineering standards in conjunction with the Engineering functions
Manages the selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.)
Provide technical expertise and advice establishing commissioning performance standards
Prepare operating, capital and manning budgets and control expenditure to agreed levels
Tracks and compiles patient enrollment, data quality and cleaning progress and overall study progress and ensures study timelines are met

Houston, TX

Country Study Manager

Houston, TX

Bailey, Schaefer and Gerlach

Houston, TX

Country Study Manager

Throughout the Study Lifetime
Leads local study teams, represents Country/Region Clinical Operation at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global Studies)
Leads the local study team, including cross functional group leaders, and ensures GLORA process is followed (Local Studies)
As requested by local Head of Clinical Operations and/or Therapeutic Area Leaders (TALs) and/or Country Medical Director participates in overall TA support in area(s) of expertise eg future landscaping activities, investigator/site development activities etc
Provides oversight, leadership and support to CRO staff (ie Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)) to ensure overall delivery at the country and site level (time, quality, cost) and interfaces regularly with local Roche Vendor Manager and CRO Management regarding feedback on CRO staff performance
Collaborates in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up
Actively conducts risk management activities (assessment, measurement and mitigation) on an ongoing basis in order to ensure overall delivery at the country and site level (time, quality, cost)

present

Detroit, MI

Senior Study Manager

Detroit, MI

Koepp, Wisozk and Wilkinson

present

Detroit, MI

Senior Study Manager

present

Study progress
Point of contact for managing/answering questions related to trial procedures and patients’ eligibility
Ensures set-up, maintenance and Quality Control of the study Trial Master File (TMF)
Manage all activities related to clinical pharmacology, complex phase I, extended phase I/IIa oncology clinical trials from the approved study concept to the clinical study report
Manage all Study Team activities as defined per SOPs/OIs and ensures the organization of regular Study Team meetings
Manage the selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.)
Forecast and track the study costs

Education Education

Bachelor’s Degree in Relevant Discipline

University of South Florida

Bachelor’s Degree in Relevant Discipline

Skills Skills

Excellent communication both written and oral skills with the ability to present findings to senior management. Strong stakeholder management skills
Ability to develop, coordinate and implement Business and Strategic Plans, to deliver business results measured in produced gold, operating cost, free cash flow, profit, capital, LOM plans, NAV and return on assets employed
A proven track record in mining studies (including experience with Brownfield projects) and demonstrated commitment to the successful implementation of the project
Good team-work skills
Good presentation skills
Ability to manage competing priorities
Good problem-solving skills
Good negotiation skills
Good interpersonal skills
10+ years’ experience in diverse technical, including sustainability and external relations, supervisory and management roles in the mining industry, at least 5 of which should be management strategic projects

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Senior Study Manager Resume Examples & Samples

Bachelor’s degree in relevant discipline
6+ years of clinical study management experience, with 2+ years of direct multinational study management experience
2+ years with oversight of CRO study execution
Comprehensive knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
Flexibility to travel up to 20%

Senior Study Manager Resume Examples & Samples

Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards
Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing
Prepare training materials and presentations related to the planning and conduct of the trial
Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget
Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and Clinical local medical organizations
Accountable for accuracy of trial information in all trial databases and tracking systems
Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD
Participate in the organization and logistics of various oversight and Advisory boards; attend meetings
Point of contact for managing/answering questions related to trial procedures and patients' eligibility
Write CTT meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team meetings. May participate in International Clinical Team meetings
Contribute to program level activities (e.g., tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions)
Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned

Study Manager Resume Examples & Samples

Coordinate and supervise the management and execution of 8-15 clinical trials
Coordinate the clinical trials feasibility process and sites selection interacting with the GMO Group Head and the relevant functions of the Medical Department and OBU
Interact with the GMO Group Head for the management of the assigned trials
Ensure timely study start-up and sites activation
Ensure that trials are conducted according to agreed plans to guarantee timely data collection and data cleaning, to achieve database lock , to respect interim analysis timelines, and to ensure that targets are fully met
Ensure sites performance for the assigned trials and sites, including ethical aspects,data quality/integrity, protocol and regulatory compliance
Set up the Study specific Investigator’s Folder for the assigned trials
Ensure ongoing updating of the databases (Clin Admin, trial DB, local databases) forthe assigned trials
Liaise with local, regional and global teams to ensure alignment of trial activities objectives and targets
Interact with the CRO to discuss time, requirements and expectations of project management and monitoring activities to be transferred, and to collect CRO budget proposal
Ensure that applicable regulations, GCP/ICH, SOPs and protocol requirements are fulfilled for the studies under her/his responsibility, including collection, quality and completeness of study documents
Support the CRAs in the identification of a proper action plan where needed for the assigned trials
Prepare and attend the project meetings as applicable and ensure prompt updateand sharing of information of project status and actions

Senior Study Manager Resume Examples & Samples

Minimum 7-10 years of experience managing clinical supplies or relevant experience
PMP certification is preferred
Ophthalmology and/or Medical Device experience a plus
Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements
English proficiency required
Proficiency in the design and use of Interactive Response Technology
Proven leadership behaviors and strong communication skills

Study Manager CPS Resume Examples & Samples

Client-focused approach to work, with the ability to interact professionally within a client organization
In-depth understanding and experience in the clinical trial process
Strong knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations
Ability to successfully work in and lead a (‘virtual team’) across locations and cultures
Carefully weigh the priority of project tasks and direct team accordingly
Enlist the support of team members in meeting goals
Give others appropriate latitude to make decisions
Understand the strengths and development areas of team members
Ability to negotiate and influence with diplomacy in order to achieve results
Ability to make decisions even in ambiguous situations to achieve project timelines and quality
Ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail to achieve project milestones
Proactive issue identification and ability to solve problems through win-win solutions by using a logical, systematic, sequential approach
Effective time management in order to meet daily metrics or team objectives
Sense of urgency in completing assigned tasks
Commitment to high quality work and respective consistent performance
Ability to gain trust and confidence with a client as well as within PAREXEL
Good learning ability
Good consulting skills
Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word
Relevant work experience as CRA or CMA, or substantial relevant experience in a similar position in clinical research
Experience in coordinating staff/teams, preferably while working in a Sr.CRA/Sr.CMA position
Individuals should have good understanding of cross functional activities related to data processing, cleaning and site management

Study Manager Pharma Dedicated Resume Examples & Samples

Bachelor's degree or licenced certified health care training or equivalent combination of education and experience
Demonstrated performance management abilities
Excellent judgment and decision making skills
Excellent interpersonal skills and problem solving ability
Knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc

CTM / Study Manager Resume Examples & Samples

Clinical research experience in all phases of study life cycle, including start up, interim and close out
Equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
Valid Driver's Licence
Extensive monitoring experience
Ability to motivate and integrate teams and teach/mentor team members
Able to effectively prioritize workload
LI-JP1

Country Study Manager Resume Examples & Samples

Leading the local/regional Study Team
Coaching, setting goals/priorities for the LST
Monitoring and optimizing LSMTs performance
Requesting necessary resources for each project
Establishing and meeting country-level commitment regarding study timelines, patient recruitment, budget
Ensure adequate tracking of the relevant information into the dedicated company tools/systems
Taking ownership for management of all aspects of the study, in close collaborations with the Medical Manager
For PA supported studies
Ensuring the sponsor conducts the study in compliance with the contract and Roche guidelines
Provides overall operational management. including study document and materials preparation (i.e. protocol, CRF,CSR, publications) site selection and patient recruitment, in collaboration with the Medical Manager
Budgeting of the Assigned studies
Forecasting the budgets
Tracking of the budget
To manage all operational aspects of studies from feasibility to study close down
Conducting Protocol and Site Feasibility
Coordinating Investigators and Steering Committee Meeting organization (if applicable)
Performing / Supporting IRB/IEC submission and contract negotiation
Ensuring SAE Reconciliation
Develop risk assessment and quality plans
Ensuring all assigned studies are undertaken in accordance to ICH/GCP standards, Roche SOPs and quality standards, local operating guidelines and local regulatory requirements
Communicating critical issues properly and ensuring they are solved on time
Providing Global Teams with feedbacks from a country perspective
Development of partnership with local Business
Development of relationships with Investigators and OLs
Training & Compliance Leadership
Accountable to ensure that the study team is duly trained and qualified
Identifying and sharing areas of best practice and process improvements
Collaborating in the preparation of audits and inspections and ensuring adequate CAPA follow up

Country Study Manager Resume Examples & Samples

The ability to effectively conduct study teams and influence in a matrix organization
The ability to motivate multi-functional teams in order for them to perform at their best
Broad knowledge of the pharmaceutical industry and experience in drug development
Proven experience in managing clinical projects and study teams, including budgets, resources and deadlines
Considerable experience with ICH/GCP and an understanding of clinical development in an international environment
Strong communication skills and you master English fluently in both speech and writing
The ability to combine integrity, courage and passion with a flexible approach to problem solving
A winning personality and the ability to motivate yourself in a busy workday

Global Study Manager Resume Examples & Samples

Provides clinical operations expertise to ensure operational feasibility and delivery
Oversees forecasting of clinical/non-clinical supplies
Delivers the operational elements of the study plan

Country Study Manager Resume Examples & Samples

Project management for the assigned clinical trials, with particular focus on the timelines planning, budget forecasting, risk management, compliance adherence and deliverables achievement
Developing and maintaining productive partnership with CROs or third parties that are actively involved in the projects and with the internal stakeholders (medical managers, global teams, etc.) that are critical for the project goals achievement
Ensuring high quality standards and high levels of efficiency and effectiveness are pursued and maintained throughout the whole study conduction process

Macs Study Manager Resume Examples & Samples

Assist with the development of the annual GMA-J research strategy for assigned therapeutic area in collaboration with GMA-J Therapeutic Area Medical Directors andoversee allocation of the budget
Oversee receipt and processing of study submissions by CRO. Review and approve research committee materials including study concepts and protocols, meeting minutes, and investigator communications
Oversees activities of the CRO, from start up, follow up and close out activities
Chair and assist Medical Directors with the conduct of cross-functional TA researchcommittee meetings used to review, approve, and track studies
Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information) from GMA-J run clinical trials in assigned TA. Ensurecoordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies
Conduct fair-market value (FMV) assessments of approved studies for assigned therapeutic area in accordance with Takeda policies and procedures
Oversee the tracking and communication of key outputs, performance metrics, and accomplishments related to GMA-J external research studies within assigned TA. Oversee the appropriate disclosure of study related information in accordance with compliance regulations
Interface with key internal and external stakeholders (including GMA-J Therapeutic Area
Collect and report GMA-J process metrics, key accomplishments, study status, andfinancial projections for assigned therapeutic area to GMA-J management team, and other internal stakeholders as appropriate
Manage, direct, coach, and develop other Study Managers as assigned

Global Study Manager Resume Examples & Samples

Key contact for clients; Liaison between Clients, CRO, and Covance
Facilitates communications between Client and extended Covance study team, including Study Design Lead and Regional Study Coordinator
Performs review of SOW to ensure quality implementation of client specifics and requirements
Manages a portfolio of global and local studies with varying complexity
Ensures that all customer expectations are documented and acted upon in compliance with regulatory requirements
Demonstrates through appropriate self organization the ability to manage conflicting priorities and to make difficult decisions
Able to act efficiently in an environment with dynamic timelines and priorities
Accountable for the implementation, monitoring and reporting of performance metrics
Actively participates in Covance CLS development through continuous process improvement, quality and productivity
Work with appropriate internal and external personnel to understand the culture and pipeline of assigned clients
Displays appropriate self organization and ability to manage conflicting priorities
Participate in functional meetings (eg. CLFs) and provide input, keeping processes up to date
Comply with CCLS Global Project Management strategy
6 years related industry experience (education can be substituted for work experience); project management experience in clinical trials would be a strong asset

Local Study Manager Resume Examples & Samples

University Degree (Minimum BSc required)
A minimum of 1-3 years clinical research experience
Demonstrates a good level of understanding of clinical research and clinical study management, and the associated regulatory, process and quality requirements
Knowledge/experience in project management and matrix team interactions
Good English language written and verbal communication skills
Advanced/expert level of MS Office (PowerPoint, Excel, Word & Outlook)
Ability to plan and forecast for study recruitment and budget management
Ability to lead, influence and coordinate clinical study teams in a matrix environment
Business, risk and financial acumen
Bilingual (French/English)
Accountable for within-country execution and delivery of assigned studies to timelines, budget and quality expectations as defined in the study protocol as well as in local regulations, IND/ICH GCP guidelines, and GSK written standards
Accountable for completeness of local trial master file for internal compliance, external regulatory or Canada Revenue Agency audits
Acts as point of conduct for trial assessment or inspection
Responsible to provide leadership and drive decisions related to the conduct of a clinical study locally including escalating issues when required
In collaboration with global and local matrix teams and functions (Quality Assurance, Regulatory affairs, Clinical Supplies, Procurement, Contracts, Legal, Monitoring, Data Management, Medical Affairs and Vendors) leads the development of site selection strategy (single or multiple study programs), local model informed consent form, local investigator meeting planning and oversight of training delivery, study performance and risk management, budget development and oversight of payments to sites and vendors
Responsible for matrix leadership and project management of country and site-level activities including oversight of site management & monitoring activities within their LOCs (Local Operating Company), including timely Monitoring Visit Report review
Serves as the operational point-of-contact between the central study team and in-country operational staff, including Clinical Research Associates (CRA) and other in-country staff aligned to the study
Responsible to identify and sharing best practices, standardizing across the LOC / region and may be involved in internal / external process improvement teams

Toxicology External Study Manager Resume Examples & Samples

Minimum BSc (in toxicology or related discipline) preferred
Familiar with technical procedures for in vivo GLP toxicology studies
Experience as a Study Director
Extensive experience working in General Toxicology in a Regulatory environment
Demonstrated expertise in General Toxicology study design and data interpretation
Demonstrated expertise in authorship and review of scientific reports and documents
Proven ability to monitor CRO studies
Demonstrated understanding of SA related disciplines such as DMPK and Pharmacology
Comprehends project toxicology concerns and works with multiple SA PTMs and Peer Review Pathologists at the same time
Recognized understanding of drug development and of all scientific aspects of a project for which specific studies are assigned
Recognized competency in general toxicology with knowledge of animal husbandry, physiology and pharmacology in diverse experimental animals (including rodents, rabbits, dogs, minipigs and primates)
Broad practical and conceptual ability in the design, conduct, data analysis and interpretation, and reporting of results from preclinical studies
Broad and integrated knowledge of all aspects of the specific discipline and associated processes including any appropriate regulatory guidelines
Extensive knowledge and expertise with one or more specialized dosing route(s) (e.g., inhalation, iv, dermal, ocular, etc.)
Demonstrated ability to apply expertise in leading and/or driving studies conducted at CROs with a track record of effective monitoring of a wide variety of general toxicology studies in multiple species at CROs
Knowledge and experience of Safety Policies, Good Laboratory Practices and relevant local and international regulations relating to the conduct of toxicology studies and the care and ethical treatment of experimental animals
Understanding of pharmaceutical industry drug development and CRO interactions
Understanding and appreciation of the role of a Study Director at a CRO
Ability to conduct critical evaluations and generate creative options for scientific approaches making prudent decisions to achieve desired outcomes

Senior Study Manager Resume Examples & Samples

Develops and Leads a Study team, manages all Study Team activities as defined per SOPs/OIs and ensures the organization of regular Study Team meetings. Develops and manages budget, timelines and quality of the study and its deliverables. Responsible for forecasting and tracking of study costs. Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT) Responsible for training and oversight of CROs to ensure compliance with timelines and budget
Together with OPL and ECL/CPL responsible for selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.), developing the total external study budget and accountable for providing monthly and yearly estimates, tracking study budget, initiating payments, providing monthly information to controlling, OPL, ECL/CPL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues
Writes protocols and amendments in collaboration with study team members. Responsible for study specific feasibility and site selection to meet study enrollment and timelines. Responsible for timely delivery of all start up activities e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight
Tracks and compiles patient enrollment, data cleaning progress and overall study progress and ensures study timelines are met. Develops appropriate study related training for monitors and site personnel according to GCP and company standard. Ensures accurate data collection, protocol adherence, patient safety, PK, PD, biopsy sample integrity and GCP compliance. Escalates severe deviations to a key parameter (i.e. recruitment, timelines, patient safety, protocol compliance, data collection/cleaning, budget) after discussing and in alignment with the Study Team to OPL and /or ECL/CPL and functional manager
Point of contact for managing/answering questions related to trial procedures and patients’ eligibility
Ensures clinical trial registry and results posting according to global requirements and guidelines, manages the study insurance according to required timelines
Ensures set-up, maintenance and Quality Control of the study Trial Master File (TMF)
Conducts lesson learned at any point in time when requested by management or any Study Team member and mandatory at study closure. The Sr. Study Manager is the main interface to all cross-functional study team members (data management, statistics, bioanalytics, clinical supplies, insurance group, clinical trial registry etc.). Moreover, he/she needs to closely interact with the OPL as well as the ECL/CPL to endure that study achievements are in line with the overall strategy and timeline for the project. The Sr. Study Manager has to ensure the adequate management of all governance committees involved in the study conduct, i.e. PRC, submission/approval by competent HA and IRBs. For the assigned studies, the Sr. Study Manager is the main contact partner for all external service providers involved in the study conduct and needs to ensure adequate oversight
Bachelor’s degree or equivalent education with 8+ years of relevant healthcare experience of which 5 years working in early clinical operations pharmaceutical including direct monitoring and clinical trial/study management experience
Ideal candidate will have solid clinical operations experience working as a study manager including 2 years of monitoring experience and a minimum of 3 years of study management experience

Study Manager Resume Examples & Samples

Manage the delivery of the asset studies in line with agreed KPI's and statement of requirements
Manage the investment approval process through a staged tollgating process
Finalise a statement of requirement for each study at inception and gain endorsement from all key stakeholders
Develop study work plans for each project at inception detailing, milestone dates, deliverables, execution strategy and resources required to deliver the study
Complete both weekly and monthly reports; liaise with the project controls function to finalise reports including safety statistics, schedule and budget progress, achievements, project risks and concerns on relevant projects
Develop study schedules for each project ensuring the schedule is aligned to the study deliverables
Develop a control budget for each study ensuring the budget is aligned to the study deliverables
Coordinate the application of project engineering standards in conjunction with the Engineering functions
Evaluate engineering consultants and service companies and subsequent engagement
Conduct reviews and designs by their party providers to align with standards
Provide technical expertise and advice establishing commissioning performance standards
Be first and foremost focused on creating a culture of care by being a visible safety leader, engaging, developing and coaching your team

Study Manager Resume Examples & Samples

Bachelors degree in clinical medicine or a life/biological science
At Least 4.5 years clinical operation experience in the top pharmaceutical or CRO
Familiar with Good Clinical Practice and relevant local regulations
Excellent command of spoken and written English and able to read it accurately
Good computer skills including proficiency with Microsoft Word, Powerpoint, Explorer and
Good team-work skills
Good negotiation skills
Experience working as a Associate Study Manager for at least 1.5 years
Advanced degree (Masters or PhD)
Experience working as a site monitor
Lead study level feasibility conduction to time and quality; Provide competitive proposal on patient
Track, oversee and manage to agreed study timelines, budget and resource; highlight significant

Senior Study Manager Resume Examples & Samples

Manage all activities related to clinical pharmacology, complex phase I, extended phase I/IIa oncology clinical trials from the approved study concept to the clinical study report
Manage all Study Team activities as defined per SOPs/OIs and ensures the organization of regular Study Team meetings
Manage the selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.)
Develop and manage the budget, timelines and quality of the study and its deliverables
Forecast and track the study costs
Ensure all relevant IT-systems are updated with current and accurate information (e.g. IMPACT)
Start up all activities e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight
Write protocols and amendments in collaboration with study team members
Manage study specific feasibility and site selection to meet study enrollment and timelines
Together with OPL and ECL/CPL be responsible for developing the total external study budget and accountable for providing monthly and yearly estimates, tracking study budget, initiating payments, providing monthly information to controlling, OPL, ECL/CPL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues
Track and compile patient enrollment, data quality and cleaning progress and overall study progress and ensures study timelines are met
Train and oversee the CROs to ensure compliance with timelines and budget
Develop appropriate study related training for monitors and site personnel according to GCP and company standards
Bachelor’s degree or equivalent education with eight (8) plus years of relevant healthcare experience of which five (5) years working in early clinical operations pharmaceutical including direct monitoring and clinical trial/study management experience
Solid clinical operations experience working as a study manager including two (2) years of monitoring experience
Manage the direct management of Phase I & IIa complex global clinical trials
In-depth knowledge of study management/project management
Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations)
Strong awareness and understanding of cultural differences as well as regional operational differences
Demonstrates leadership in project management and vendor management
Comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters
Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, and excellent interpersonal, decision-making and issue resolution skills
Effective planning and organization skills, attention to detail and excellent follow through
A minimum of three (3) years of study management experience

Senior Study Manager Resume Examples & Samples

Manages and is responsible for all aspects of assigned Phase I and extended Phase I/IIa complex clinical trials, within the approved Clinical Sciences Development Plan (CSDP)
Manages all study related activities from approved study concept to the final clinical research report (CSR) and ensures that study execution is on track
As a member of the Operational Sub-team of the ECT/CST he/she provides input to this team to ensure there is accurate tracking. Within the framework given by the ECL/CPL and the OPL, the Sr. Study Manager develops controls and is accountable for the overall study budget and informs the team on budget issues and/or concerns
Implements, manages and leads a cross functional study team for the entire duration of the study

CTS Study Manager Resume Examples & Samples

Planning, implementation and management of the logistics network for international clinical studies requiring a complex supply concept and in close collaboration with internal global specialty departments and external service providers
Planning and implementation of the packaging design in compliance with country regulations and study specific requirements
Development and maintenance of clinical supply material demand plans and adaptation to study specific needs
Identification of quality standards and product specifications for all clinical supply materials in cooperation with global specialty departments
Determination of product demands and coordination of the supply with the production departments at all CSLB manufacturing sites
Sourcing of all non CSL Behring clinical supply materials within the required specification via international wholesalers, manufacturers or other service providers
Development and maintenance of the logistics and product budget for clinical studies
Coordination of a timely, high quality and on demand packaging and supply of all medicinal products and ancillary supplies
Leading clinical supply meetings with internal and external specialty groups
Professional management of internal and external team members supporting supply management activities
Generation or review of study documents relevant for regulatory submission (e.g. IMP handling instructions for investigators and study subjects, drug accountability forms, study protocol)
Preparation and conduct of trainings and presentations on international investigator meetings
Generation of documents for study sites enabling a GCP and GMP compliant documentation of handling and usage of the study medication as well as the regular review of the completed documentation
Training of external study monitors and internal global study teams in regards to study specific supply chain processes
Generation of final drug reconciliation reports for the entire clinical study
Visiting study sites to discuss options for the optimization of the study specific IMP supply and IMP documentation
Contribution to the selection of external service providers
Generation of study specific request for proposals and review of the quotes
Management of clinical manufacturing organizations (CMO) in regards to the contracted study and leading meetings with them
Processing of deviations reported from external service providers in compliance with company standards and existing quality agreements
Participation in business review meetings with external service providers
Review of study specific software specifications (IRT) to close cooperation with IT experts
Contribution to the development of test plans for software applications and participation in user acceptance tests
Maintenance of data in IRT systems and provision of status reports
Ensuring that the internal systems (e.g. SAP, APO) contain the correct data
Generation and monitoring of the study specific logistics and product budget
Generation of study specific cost reports
Monitoring of costs from external service providers according to the agreed upon budget targets
Preparation of inspections and audits regarding IMP supply related topics
Participation in inspections and audits as IMP supply representative from the sponsor site
Timely processing and completion of audit and inspection findings
Generation of SOPs and other quality related documents
Participation as CTS representative in international study execution team meetings
A degree (BSc) or equivalent in life science, logistics or project management. Other degrees and certifications considered if commensurate with related clinical research or clinical supply management experience
Professional experience: at least 4-5 years’ relevant experience in clinical supply management or R&D project management
Fluency in German is a plus

IIT Study Manager Resume Examples & Samples

Set up Haematology, Oncology and Inflammation & Immunology (I&I) IITs from first receipt of proposal to study closure
Manage the process and track drug orders for Romidepsin Named Patient Program, where appropriate
Maintain a database to log and track IIT status
Provide monthly status reports, dash boards and other activity summaries to manager, MD and the wider Business Unit where required in order to enhance awareness of the IIT programme
Provide point contact for all IIT related queries including drug supply, contract status, protocol amendments and safety updates
Appropriate storage of electronic and hard copy essential documentation
Create SOPs/WPs for local IIT management
Communication with/visits to sites to assist with proposals, review IIT status or drug accountability
Assist Regional Medical Liaisons (RMLs) with new IIT proposals for support, ensure proposals are in line with Celgene Global Research Strategy and, where appropriate, champion the proposal at review meetings
Assist in contract negotiations with investigators and Sponsors as required, providing point contact for European contract and legal teams
Work with Celgene IMSC department to process and track drug orders for IITs. Ensure all key stages and activities for studies are established and achieved
Provide IMSC department with drug forecasts for all IITs and ensure all documentation is available for QP release
Liaise with RML team or other Celgene staff as required to assess IIT status and provide support
Interact with EU Medical Department and Medical Affairs personnel to ensure standardisation and implementation of best standards and practices
Manage and respond to queries related to drug supply, logistics and regulatory approval
Manage the internal review and tracking of all study documentation, including amendments, publications, reports and safety reports
Provide RMLs with latest safety updates and procedural changes related to IIT management and ensure these are implemented
Ensure consistent implementation of best practice
Ensure accurate and accessible storage of study documents
Maintenance of electronic and existing paper folders as repositories for all relevant IIT study documentation (inc IBs, CDAs, Contracts, CTAs, Ethics)
Develop capacity for expansion of IIT studies
Build capacity of the function to deal with future trials
Organise Investigator/Researcher meetings as appropriate
Manage IITs of strategic importance to the UK affiliate via Collaborative Model process
Life Science degree (prerequisite)
Relevant experience, preferably within the pharmaceutical industry (prerequisite)
Experience in clinical research and/or Project Management (prerequisite)
Strong Scientific Background
Strong identification with Celgene’s Values
Previous Clinical Research/Investigator Initiated Trials experience
Excellent organizational skills and strong interpersonal skills
Knowledge of Haematology, Oncology or Inflammation & Immunology an advantage but not a prerequisite

Senior Study Manager Resume Examples & Samples

Accountable for the operational planning, feasibility, and execution of a clinical protocol
May lead team in key study planning, development and execution elements (e.g., data management deliverables, protocol level plans/timelines, country/site selection, system updates, Investigator Meeting planning, communication plans, preparation of status update reports, study closeout activities)
May serve as the clinical trial team (CTT) lead
Leads team for timeline management, risk identification and mitigation, issue resolution
May facilitate and collaborate with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc) in support of clinical study objectives
Accountable for managing any study specific partners and/or vendors

Study Manager Resume Examples & Samples

Displays leadership to ensure successful interactions between Covance study team members needed to provide seamless study delivery to the client
Provides project management oversight; focusing on key client deliverables through budget, risk, and milestone management
Facilitates communications between Client and extended Covance study team
Writes and reviews the SOW to ensure quality implementation of client specifics and requirements
Manages a portfolio of global, high-complexity studies
Acts as an ambassador on behalf of the client within Covance CLS and across Covance business units; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills
Demonstrates strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget
Comply with CCLS Vaccine and Novel Immunotherapeutics as well as Global Project Management strategy
Support a culture of continuous improvement, quality and productivity
3-5 years related industry experience; project management experience in vaccine and/or vaccine and immunotherapeutic or immuno-oncology clinical trials would be a strong asset

Local Study Manager Resume Examples & Samples

Accountability for high quality within-country execution and delivery of assigned studies
The development and maintenance of country study plans including responsibility for: forecasts, budgets, resource estimates, milestones, timelines, quality and risk planning
Providing leadership and driving decisions related to the conduct of local clinical studies including escalating issues where needed
Responsibility for the selection & management of local vendors where required
Acting as a point of contact for regulatory/compliance audits of assigned studies
Providing input into feasibility and study design
Ensuring that there is adequate and appropriate training in place for CRAs and Investigator sites
Identifying and sharing opportunities for process improvement and driving a culture of operational excellence as well as educating teams on best practice and ensuring consistency in delivery
Developing and negotiating Clinical Trial Agreements with the support of the legal team
Experience in a Clinical Study Lead or an equivalent role within the pharmaceutical sector
Proven experience managing multiple external and internal stakeholders in a complex, matrix environment
Strong leadership skills with extensive experience in project management and risk management
Extensive and varied knowledge of all aspects of clinical trial management including but not limited to: drug development, ICH-GCP guidelines, sample management and quality & compliance requirements
Ability and experience leading and working with teams across functional and geographical boundaries
Well developed analytical and problem solving skills

Study Manager Resume Examples & Samples

Project Administration - Assists with managing the executed contract and financial aspects of assigned projects. Reviews study budgets and expenses to ensure all study related contractual and budgeting issues are upheld and performed. May oversee and tracks site payment issues as required. Alerts Finance to the need for Customer invoicing. Reviews protocol and draft Case Report Forms for consistency within each document. Develops and maintains project plans for the study in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WI). Maintains effective communication with project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication. Performs ongoing review of project financial status of studies within his/her responsibility; alerts senior management to potential issues and ensuring necessary corrective action is taken. Oversees the regulatory document collection and submission process. Ensures project documentation, including Trial Master File, are complete and audit ready. Assists in the negotiation and contracting process with outside vendors such as laboratories, printers, drug packaging, labeling and storage, and Interactive Voice Response System companies
Reporting - Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports, and functional area plans to appropriate team members and senior management
Communication - Maintains effective communication with project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication. Prepares information for internal review meetings. May present prepared information at project review meetings. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans
Business Development - May participate in proposal and investigator grant determination. May participate in Customer proposal development
Knowledge/Training – Develops knowledge of current therapeutic environment. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
Project Leadership - May manage a project under supervision. Acts as a liaison and facilitator between other departments within the company to ensure project related tasks and/or issues are addressed
Management - May have limited line management responsibility

Local Study Manager Resume Examples & Samples

BS/BA degree in a health-related science
A minimum of 5 years clinical/research experience (can be in Study Management, Field Monitoring or similar experience)
Demonstrated high level of understanding of clinical research and clinical trial management, and the associated regulatory, process and quality requirements
Demonstrated strong knowledge and experience in project management and matrix team interactions
Demonstrated operational expertise in risk management and contingency planning, understanding of local regulations, GCP/ICH-guidelines and GSK SOPs/POLs/guidelines
Experience with Healthy Volunteer studies
Availability and willingness to travel for project related activities as required (e.g., Investigator Meeting attendance, etc.)
Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
Demonstrated excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements
Experience with discipline of risk-based planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics
Strong project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available); projects, manages and reports budget information (i.e., demonstrates business and financial acumen)
Ability to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others
Able to set and manage priorities, resources, performance targets in a local environment
Effectively plans, communicates, coordinates and facilitates delivery of team objectives
Ability to understand the impact of technology on studies and to use/develop computer skills while making appropriate use of GSK Pharma systems/software
Experience applying industry best practices to the execution of clinical studies within country to improve time, budget and resource efficiency
Demonstrated conceptual, analytical and strategic thinking
Effective problem solving and conflict resolution skills
Demonstrated good written and verbal communication skills, and proven negotiation skills

Study Manager Resume Examples & Samples

Manage risk through the study and project phases of this major development in a large complex brownfield environment
Develop effective communication processes to maintain and motivate employees ensuring they work to achieve the best interest of Olympic Dam and are aware of and strive for the goals of the team
Coordinate study activities to maximise value by lowering operating cost, optimising schedules and implementing prudent capital plans
Prepare operating, capital and manning budgets and control expenditure to agreed levels
Ensure that the Investment Case is framed and developed according to our guidelines and procedures
Maintain open and efficient communication channels with Olympic Dam Managers and Staff to share knowledge, contacts, experience and expertise
Maintain strong and transparent relationships with internal and external Stakeholders and to related projects
Leading by example; hold yourself and others accountable and coach others in "Safety Leadership"
Mining industry operational, project and investment case development
Delivering very large multi-disciplinary projects in a brownfield environment
Leading and managing a team
Working using a range of study / project delivery models
Driving a study / project to a successful conclusion

Senior Study Manager Resume Examples & Samples

Manages and is responsible for all activities related to clinical pharmacology, complex phase I, extended phase I/IIa oncology clinical trials from the approved study concept to the clinical study report
Manages the selection and oversight of External Suppliers (e.g. site management and
Monitoring CROs, Central Labs, central ECG reading center, etc.)
Develops and manages budget, timelines and quality of the study and its deliverables
Responsible for forecasting and tracking of study costs. Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT)
Writes protocols and amendments in collaboration with study team members
Together with OPL and ECL/CPL responsible for developing the total external study budget and accountable for providing monthly and yearly estimates, tracking study budget, initiating payments, providing monthly information to controlling, OPL, ECL/CPL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues
Tracks and compiles patient enrollment, data quality and cleaning progress and overall study progress and ensures study timelines are met
Responsible for training and oversight of CROs to ensure compliance with timelines and budget

Senior Study Manager Resume Examples & Samples

Manages and is responsible for all activities related to global and local complex clinical trials from the approved Study Concept to the Clinical Study Report
Develops the comprehensive and operational plans for the study
Manages Operational Study feasibility conducted by country organizations to determine study feasibility and final country selections
Based on study feasibility summary, develops study timelines, milestones, outsourcing plan and proposed external study budget
Accountable for the development of the Core Study Documents and processes including: Data Collection tool (Remote Data Entry/Case Report Form), Study Monitoring Plan, Drug Forecasting and Medical Research Report
Responsible for Study Protocol and ensuring adequate Investigator selection in each country to meet study enrollment and timelines. These processes and documents must be consistent with the market driven Study Concept provided by the GCL and requires significant collaboration with StudyTeam members
Responsible for developing the total external study budget and accountable for providing monthly and yearly estimates
Responsible for tracking study budget, initiating payments,providing monthly information to Controlling and GCL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues
Identifies, implements, leads and manages a global cross-functional Study Team for the duration of the study, working with functional line management to identify team members and resolve issues
Disseminates relevant information to team members in effective and timely manner
Represents the Global Study Team as a member of the Global Clinical Project Team
Manages, tracks, and responsible for ensuring ongoing study activities, study execution and timelines are met. Tracks and compiles patient enrollment, data cleaning progress and overall
Study progress
Assesses and analyzes study information for variances and takes necessary actions within his/her responsibility to resolve variances. If necessary, initiates action with functional heads to resolve variances
Develops appropriate study related training for Study Team representatives (in particular for monitors) and site personnel according to GCP and BSP Global Development Standards to ensure quality and requirements necessary for global regulatory approvals and marketing needs are met
Manages Contract Research Organizations (CROs) and External Suppliers. Selects and develops contract specifications for external supplier in collaboration with Global External Supplier Manager
Responsible for defining outsourced tasks, developing outsourcing plan, training and managing external suppliers to ensure compliance with timelines and budget. Identify milestone achievements to initiate payments to external suppliers

Study Manager, CPS Resume Examples & Samples

Lead of the local (and member of the international) study team in the capacity of UK/Ireland Study Manager
Select trial sites across the UK & Ireland and manage clinical investigators/site staff with the appropriate expertise, resource and facilities to conduct and deliver the trial according to the client protocol and SOPs in compliance with ICH-GCP and all other relevant external regulations
Ensure approval by national ethics/local sites of the study and all subsequent amendments done in a timely manner to ensure recruitment & quality targets are achieved
Close liaison with Local Regulatory Affairs to ensure Competent Authorities approvals are in place
Set up and manage any external parties to achieve all local (UK/Ireland) trial targets
Overall responsibility for delivering clinical trials performed in the UK & Ireland to time, within budget and to the highest possible quality standards to fulfil the requirements of the drug development plan
Manage, mentor and support Clinical Research Associate and Clinical Trials Assistant allocated, to ensure efficient and effective trial conduct and positively promote teamwork

Senior Study Manager Resume Examples & Samples

Responsible for Study Protocol and ensuring adequate Investigator selection in each country to meet study enrollment and timelines. These processes and documents must be consistent with the market driven Study Concept provided by the GCL and requires significant collaboration with Study Team members
Responsible for tracking study budget, initiating payments, providing monthly information to Controlling and GCL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues
Manages, tracks, and responsible for ensuring ongoing study activities, study execution and timelines are met. Tracks and compiles patient enrollment, data cleaning progress and overall study progress
Bachelor’s degree or equivalent education with 8+ years of relevant healthcare experience of which 5 years clinical operations in the pharmaceutical industry including direct monitoring and clinical trial/study management experience
In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations)
Awareness and understanding of cultural differences as well as regional operational differences
Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, excellent interpersonal skills

Study Manager Resume Examples & Samples

Manages and is responsible for all activities related to clinical pharmacology, complex phase I, extended phase I/IIa clinical trials from the approved study concept to the clinical study report
Manages all Study Team activities as defined per SOPs/OIs and ensures the organization of regular Study Team meetings
Manages the selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.)
Develops and manages budget, timelines and quality of the study and its deliverables. Responsible for forecasting and tracking of study costs. Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT)
Responsible for all start up activities e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight
Occasionally writes protocols and amendments in collaboration with study team members
Responsible for study specific feasibility and site selection to meet study enrollment and timelines
Develops appropriate study related training for monitors and site personnel according to GCP and company standards

Study Manager Resume Examples & Samples

Solid clinical operations experience as a study manager working in early development managing patient studies or be a research nurse with the following experience: Study coordinator experience on Phase I clinical trials in a hospital research setting (a General Clinical Research Center, for example); Experience as a Study Manager/Clinical Trial Leader for a pharmaceutical company; Experience as a CRA on Phase I trials
In depth knowledge of the clinical trial management process including monitoring and study management processes, regulatory requirements, drug safety requirements, data management and statistical processes and budget and financial tracking
Proven project/external vendor management skills, including effective planning and organization skills, attention to detail and excellent follow through
The position also requires awareness and understanding of cultural differences as well as regional operational differences

Pre-study Manager Resume Examples & Samples

Drive product maintenance pre-studies for Product Modification Requests (PMR) HD engines Europe and Global,
Drive cross functional decision inputs for Heavy Duty Engines in Estimation and Decision meetings,
Secure pre-study lead-time achievement with your cross functional team,
Coordinate with key accounts of Volvo Construction Equipment (VCE), Volvo Penta (VP), Volvo Bus (VBC)
Ensure that product changes proposed includes appropriate validation plans with constant quality focus,
Secure that proposed product changes are consistent with the quality targets
Powertrain product know-how
Structured
Management experience as group leader
University degree BSc, or equivalent
Project processes education

Senior Study Manager Resume Examples & Samples

Plan and manage highly complex and/or strategic priority clinical studies; characterized by challenging protocol/study designs, atypical study operations, high study financial costs, large global clinical trial scope and/or new areas of investigation
Manage and be responsible for all activities related to global and/or local clinical trials from the study concept to the clinical study research report
Lead the Study Team, from the request of core Study Team members to study close-out contributes to the Study Concept development with regard to its operational aspects, if assigned already
Develop the comprehensive overview and operational plans for the study by developing and maintaining the Study Plan
Contribute to risk management activities of GCT (Global Clinical Team), and responsible for study specific oversight and risk mitigation activities as described in the Study Plan
Support strategic study feasibility and manages operational study feasibility conducted by country organization to determine study feasibility and final country selection
Develop study timelines based on the feasibility summary, milestones, outsourcing plan and proposed external study budget
Work in close collaboration with the study team and assists in the development of the core study documents and processes
Assists in the preparation of the study protocol
Be responsible for developing the total external study budget and accountable for providing monthly and yearly estimates
Be accountable for tracking study budget, initiating payments, forecasting and providing monthly information to controlling and GCL (Global Clinical Leader), identifying budget/estimate issues
Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT)
Identify, implement, lead and manage a cross-functional core Study Team for the duration of the study, working with functional line management to identify team members and resolve issues. The Core study team members include: Study Medical Expert, Study Statistician, Study Data Manager and the Study Lead Monitor disseminates relevant information to team members in effective and timely manner
Represent the study team as a member of the Global Clinical Team
Manage, track, and be responsible for ensuring ongoing study activities, study execution and timelines are met
Track and compile patient enrollment, data cleaning progress and overall study progress
Assess and analyze study information for variances and takes necessary actions within his/her responsibility to resolve variances
Initiate actions with functional heads to resolve variances
Develops appropriate study related training for study team representatives (in particular for Monitors) and site personnel according to GCP and BHP global development standards to ensure quality and requirements necessary for global regulatory approvals and marketing needs are met
Act as Responsible Outsourcing Person in outsourced studies and manages the selection and oversight of other external suppliers (e.g. Central Labs, central ECG reading center, etc.)
Select and develop contract specifications for external supplier in collaboration with global strategic sourcing manager
Be responsible for defining outsourced tasks, developing outsourcing plan, training and managing external suppliers to ensure compliance with timelines and budget
Identifies milestone achievements to initiate payments to external suppliers
Advise and manage Study Committees and external expertise
Bachelor’s degree with eight (8)+ years’ of relevant healthcare experience which includes five (5) years clinical operations in the pharmaceutical industry including direct monitoring and clinical trial/study management experience
The incumbent is responsible for management of complex Phase II - IV global clinical trials. This requires an in-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations) with a proven track-record leading the initiation and completion of clinical studies
The position also requires awareness and understanding of cultural differences as well as regional operational differences. The incumbent requires comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters
Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, and excellent interpersonal, decision-making and issue resolution skills are required
In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through. The senior Study Manager is able to manage conflicts in the team effectively
Of the five (5) years of clinical operations experience (mentioned in the requirements above) , three (3) years of monitoring experience and two (2) years of study management experience are preferred

Los Bronces Underground Study Manager Resume Examples & Samples

Conduct analyses of early-stage, conceptual level and PFS A studies with the aim of identifying potentially value-creating resource and technology endowment opportunities for the Group, using internal or external resources
Support Group Projects by critically evaluating identified opportunities, and providing alternative approaches and ways of thinking about resources, technology and project structuring
Coordinate the key inputs and outputs of the study process, building collaborative relationships with key stakeholders both within Group T&S and the wider Anglo American Group
Analyse the financial assumptions and models on projects being presented for approval
Support business case development by identifying and understanding the full resource extraction value chain and its key drivers, then executing the necessary investigation and techno-economic analysis to ensure optimal project-related decision-making
Develop financial models which bridge technical input parameters and commercial factors (including balance sheet and cash flow detail) to facilitate scenario modelling, and to support the management of uncertainty in critical project decisions
Conduct high level optimisation exercises in concept and pre-feasibility stages, incorporating an appreciation of factors such as cost-volume relationships, capital designed relationships and ore body signature characteristics
Lead team of Study managers to change and complete effective evaluation of study options
Visibly demonstrate SHE leadership behaviour
An undergraduate qualification (Bachelors / Honours degree or equivalent) in a relevant technical discipline
A postgraduate qualification (Masters / Doctoral degree or equivalent) in a relevant technical discipline OR a proven track record of extensive practical experience in a role and context of similar complexity
Proven ability to understand and be able to synthesise cross-functional information from functions (This will include geology, metallurgy/process, mine engineering, geostatistical modelling, operations, projects, information technology, tax, treasury, financials, environmental, social, political, land, legal, human resources, supply chain, and security)
Overall project management of a few (1 to 2 )complex evaluations at one time
Proven ability work within and understand other cultures, including language skills
Ability to challenge the status quo, drive innovation, and hold large cross functional teams accountable for results and recommendations that drive critical corporate decisions
Ability to communicate complex information in varying forms (verbal, presentation, report) to audiences ranging from technical team members to CEOs
Strong ability to lead and set vision and direction for individual evaluations
A proven track record in early project development and value generation
Proven ability to lead and motivate diverse cross functional team members from different cultures, think innovatively, execute projects, communicate effectively and deliver results
Proven ability to justify, budget, execute and manage large programs
Experience in wide variety of projects, with varying financial drivers, varying project risks and project costs up to and including $1B
Must be able to evaluate potential projects and develop and present presentations for senior executives which are accurate and concise and clearly identify risk/opportunity
Strong track record of leading the analysis and early business/engineering to establish the conceptual viability of step changes in resource and technology endowment opportunities within a global, multi-commodity mining organisation
A demonstrated thought leader and respected as a considered a global expert in the identification of potentially value-creating resource and technology endowment within the mining/ extractives industry
Experience in the development of analytical models to validate the inputs to and assumptions of studies
Significant proof of leadership and practical experience in Project Management concepts and principles, and the application thereof in a technical environment
Technical experience in one or more relevant technical disciplines (e.g. Mining, Engineering, Project Management, Geosciences or Processing) would be an advantage
Demonstrated experience in a senior people leadership role within a technical environment, including the coordination of knowledge sharing across a discipline, managing workload and reviewing the work of others to ensure consistency with task requirements

Study Manager Resume Examples & Samples

Communication - Maintains timely and effective communication among team members and site staff. Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution
Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested. Responds to findings without oversight. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities
Monitoring - Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits superior time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits
Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Highly proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed
Reporting and Tracking - Completes and submits reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit
Administrative - Prepares for and attends Investigator meetings. May attend Customer and Business Development meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring and/or training plans

Study Manager Resume Examples & Samples

Integration of the project study recommendations with operational business plans
Consistent and constant engagement with the Site Leadership Team and ensure key issues are socialised in advance
Responding to Joint Venture requirements
Tertiary qualification in a Mining Discipline or similar degree and preferably additional management qualifications including project management
10+ years’ experience in diverse technical, including sustainability and external relations, supervisory and management roles in the mining industry, at least 5 of which should be management strategic projects
A demonstrated commitment to safety in design
A proven track record in mining studies (including experience with Brownfield projects) and demonstrated commitment to the successful implementation of the project
Demonstrated experience in inputting physical data and running financial models for a mining related business
Ability to develop, coordinate and implement Business and Strategic Plans, to deliver business results measured in produced gold, operating cost, free cash flow, profit, capital, LOM plans, NAV and return on assets employed
Excellent communication both written and oral skills with the ability to present findings to senior management. Strong stakeholder management skills