Trial Manager Resume Samples

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K Kunde

Kiana

Kunde

552 Vincenzo Square

Los Angeles

+1 (555) 171 8685

552 Vincenzo Square

Los Angeles

Phone

p +1 (555) 171 8685

Experience Experience

Dallas, TX

Trial Manager

Dallas, TX

Hartmann, Homenick and Tillman

Dallas, TX

Trial Manager

Trial Manager_Further Particulars
Ensure enrollment commitments meet the projected enrollment across all sites at the clinical trial level, monitors patient recruitment at the study level, and ensure timely and accurate documentation and communication of study progress and issue escalation
Contribute to the long term management of the section/centre, interpreting college strategies into work priorities
Manage the performance, induction and development of the team
Support and guide team members in welfare issues, escalating as necessary to specialist support areas
To prepare research ethics and research governance applications
Develop networks within and across the centre to ensure the success of the team’s objectives and long term plans

New York, NY

Global Trial Manager

New York, NY

Turner-Ward

New York, NY

Global Trial Manager

Perform review of ESP invoices to ensure that work is performed in accordance with scope of work
Oversee the performance of all study ESPs to ensure compliance with study protocol and in accordance with of scope of work
Forecast and manage global IMP and clinical study supplies. Works closely with the Technical Operations-Clinical Trial Supply Group throughout the study
May provide operational input to protocol development, preparation of GCDO Collaborative Study proposal documents and the Request for Service (RFS) process
Pro-actively manage patient recruitment and retention and develop contingency plans at a regional/global level
Oversee performance of ESPs to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to GTL
Assist and provide input into the Clinical Trial Plan (CTP)

present

San Francisco, CA

Senior Local Trial Manager

San Francisco, CA

Koelpin-Torphy

present

San Francisco, CA

Senior Local Trial Manager

present

Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, Site Managers and other LTMs
Create various trial related documents including Country Feasibility Report, Trial Master Spreadsheet and country specific ICF template
Collaborate with Clinical Data Manager (CDM) during analyses to ensure report accuracy and to resolve site specific data issues
Maintain/update the electronic files and ensure all activities are executed according to internal SOPs and instructions to use
He/she will also create various trial related documents including Country Feasibility Report, Trial Master Spreadsheet and country specific ICF template
Additionally, he/she will partner with the Clinical Trial Assistant CTA/ Investigator Document Assistants IDA, Site Manager SM, Contracts and Grants group and Global Trial Manager GTM to ensure overall site management while performing trial related activities for assigned protocols
He/she will work with SM to ensure Corrective Action Plan is completed for QA site audits and ensure, in collaboration with SM, the timely and accurate data collection, documentation and communication of study progress and issues

Education Education

Bachelor’s Degree in Life Science

University of Oregon

Bachelor’s Degree in Life Science

Skills Skills

Ability to communicate detailed and complex information effectively and professionally to a wide range of people
Proficient in speaking and writing the country language and English language. Good written and oral skills
Proven ability to develop networks in order to contribute to long term developments
Should have experience with and be able to participate on global, regional, or local teams in a virtual environment
Monitors overall status and quality of data being collected during the in-life portion of a trial
Ability to actively participate and contribute to the productivity and cohesiveness of the team
Good analytical skills and solution oriented, actively seeking input from others
Specialist knowledge of appropriate trial governance, systems and processes
Strong organization and management skills
Familiar and comfortable with database concepts and tools to manage, extract, and report clinical data

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Dsm Trial Manager Resume Examples & Samples

Advanced degree in Science, Engineering or related discipline
4+ years of experience in clinical trial drug supply management required
Knowledge of the drug development process and relevant regulations (e.g., GMP, HSE)

Local Trial Manager Resume Examples & Samples

At least 3 years of experience in monitoring of clinical trials
Experience in project management (preferable)
Sound understanding of drug development process including ICH/GCP and local regulatory requirements
Ability to make decisions under time pressure and prioritize accordingly
Ability to analyze data and plan accordingly
Ability to identify risks and implement corrective/preventive actions
Excellent communication, networking and influencing skills
Proficiency in speaking and writing in English
Clinical Trial Coordination

Local Trial Manager Resume Examples & Samples

Collaborates with the CPL, GTM, local management/Country Head and Protocol Owner to select final site list
Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting
Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints). Uses study tools and management reports available to analyze trial progress
May lead negotiation of trial site contracts and budgets, with the assistant from a LTM II or III. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines
Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes)
Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed
Actively contributes to process improvement

Senior Trial Manager Resume Examples & Samples

Collaborates with the CPL, GTM, country TMs (if applicable), functional management and Protocol Owner to select final site list
Contributes input to the development of e.g. the Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for trials to which no GTM is assigned
Leads and coordinates local trial team(s) activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting (if applicable)
Monitors country and overall study progress (if applicable) and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to CPL, GTM, protocol owner and study management teams e.g. ensures appropriate documentation and follow-up related to protocol issue escalation
May submit requests for vendor services and may support vendor selection. Reviews and approves site and local vendor invoices as required
Conducts trial team meetings and provides or facilitates TM/SM training when needed (i.e. implementation of study amendment-and changes in study related processes)
Works with TMs/SMs to ensure CAPAs are developed and implemented for audits and inspection or any quality related visits
Acts as primary local or multi country contact in GCO for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, trial coordinators, other site staff, key contacts in Early Development and/or Clinical Pharmacology and other internal stakeholders
May represent functional area in process initiatives
A minimum of a 4-year Bachelor’s degree is required OR equivalent clinical experience considered
Minimum of 6 or more years of pharmaceutical and/or clinical trial experience is preferred
Experience in Early Development & Clinical Pharmacology clinical preferred
Experience in Oncology is a required
Solid understanding of the drug development process including ICH/GCP and local regulatory requirements
Proficient in speaking and writing the country language and English language
Willingness to travel with occasional/regular overnight stay away from home depending on the region
Ability to work on multiple trials in parallel in different disease areas.Clinical Trial Administration

Senior Trial Manager M/F Resume Examples & Samples

Besides the LTM tasks, a Sr. TM may also be responsible for GTM and SM tasks depending on the studies assigned. For the GTM and SM tasks reference is made to the Job Description for the ED&CP GTM and SM and the GCO Procedural Documents
Is responsible for study feasibility and site/lab assessments, providing recommendation of suitable sites for selection to participate in the trial. Ensures appropriate follow-up of pre-trial visit reports
Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate
Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and SharePoints sites). Uses study tools and management reports available to analyze trial progress
May lead and coordinate negotiation of trial site contracts and budgets. May be responsible for forecasts and management of GCO budget to ensure accurate finance reporting and trial delivered within budget. Adheres to finance reporting deliverables and timelines
Accountable for set-up and conduct of Investigator Meetings (either local or multi-country)
Reviews and approves site and local vendor invoices an required
Acts as expert for assigned protocols. Develops therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams
Actively contributes to process improvement initiatives, and training and mentoring of Site Managers, Clinical Trial Assistants and other TMs
Strong experience in managing and monitoring oncology and/or hematology trials
University degree in Life Sciences, Nursing, or related scientific field is required
Minimum 4 years of pharmaceutical and/or clinical trial experience is preferred
Proficient in speaking and writing French and English language
Shows leadership skills
Flexible mindset and ability to work at a fast pace within small exploratory study teams
Ability to work on multiple trials in parallel in different disease areasClinical Trial Coordination

Local Trial Manager Resume Examples & Samples

Responsible and strong customer orientation
Feels comfortable working in an international and changing environment
Team building attitude
Knows how to set priorities, especially under time pressure
Takes initiative and acts in a pro-active way

Global Trial Manager Resume Examples & Samples

Manage regional or global Medical Affairs interventional, non-interventional clinical trials, name patient /compassionate use programs and/or investigators initiated studies from project planning, feasibility through to database lock, site closure and study report within quality guidelines, timelines and budget
Work with the appropriate vendors and internal stakeholders to make sure study is started up, recruited and completed on time in accordance with the protocol and all applicable regulations
Pro-actively manage patient recruitment and retention and develop contingency plans at a regional/global level
Measure progress against goals to achieve clinical research targets
Manage the budget associated with the conduct of the trials
Ensure timely and accurate documentation, communication and follow-up of study progress and issues, including vendor oversight
Ensure that required reports are generated within organizational guidelines
Interact with multifunctional teams within and outside of GCO. e.g. regional and country medical affair team, GDO functions including GCO-TCSM, IDS, B&P and Medical writing, Quality Management & Training group, Vendor Management, planning group, CSU, and GPS, GCQA, Regulatory affair, BRM, finance and legal
At least 6-8 years experience in clinical trials with a pharmaceutical company and/or a CRO
Have been involved with regional projects/initiatives and understand the complexity of working across multiple geographies
Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations, in-depth knowledge of Medical Affairs or global/multi-country clinical operations, full understanding on all logistical aspects when running interventional and/or non-interventional clinical trials regionally, and good understanding on the therapeutic areas where J&J is involved
Strong ability to handle multiple tasks and priorities
Excellent written and verbal communication in English
Highly motivated, energetic, proactive, enthusiastic and an independent thinker, while being an excellent team player
Results driven and innovative, take initiative,
Have excellent problem solving and decision making skills
Excellent communicator, with excellent interpersonal skills and diplomacy
Cross-cultural savvyClinical Trial Coordination

Local Trial Manager Resume Examples & Samples

Comply with requests from QA and auditors
Responsible for managing the mCTA data oversight: provide qualitative and quantitative input into any revisions of the mCTA and maintain metrics on herence to mCTA standards, time to contract sign off to inform strategic discussions with the Research networks
Establish and maintain excellent working relationships and networking with external stakeholders, in particular hospital administration and contracting and internal stakeholders, including but not limited by Legal Affairs, Health Care Compliance and global C&G

Local Trial Manager Resume Examples & Samples

Works with SM to ensure CAPP is implemented for audits nd inspection or any quality related visits
Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, Site Managers and other LTMs
A minimum of a BA/BS degree is required
A degree in a health or science related field is preferred
Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements
Solid communication and computer skills required
Good written and oral communication skills.Clinical Trial Administration

Trial Manager Resume Examples & Samples

Project planning, initiation, execution, change control, and closing
Project team development, project team leadership, meeting management, and resource coordination
Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary
Management of customer / stakeholder expectations; facilitation of cross-functional decisions
Defines trial-level requirements for quality data collection and validation at the trial level
Reads and interprets the clinical protocol from a clinical data management perspective
Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility
Engages with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs (including timing), and confirm all data management deliverables and services required for a trial
Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation
Facilitates assessment and processing of standards and change requests
At least 3 years' of Clinical Data Management Experience
Full life-cycle experience in clinical data management (data collection system development through database lock and close-out and submissions
At least 1 year experience working with formal project management tools (MS Project) and processes
Understanding of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle
Familiar and comfortable with database concepts and tools to manage, extract, and report clinical data
Strong organization and management skills
Must be able to communicate effectively both orally and in written form with technical and business areas

Senior Local Trial Manager Resume Examples & Samples

A minimum of a Bachelor's degree (or equivalent experience may be applicable) is required. Degree in a health or science major is preferred
A Minimum of 4 or more years of pharmaceutical experience is required
Prior experience with the therapeutic areas experience Neuroscience / Immunology is preferred
Previous clinical operations experience preferred
Solid understanding of the drug development process including GCP and FDA Code of Federal Regulations required
Minimal travel may be required
This position is located in Spring House, PA (Other locations possible: Titusville, NJ; Raritan, NJ or Remote locations considered.)Clinical Trial Administration

Local Trial Manager Resume Examples & Samples

Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and GTM. Implements any local criteria for site selection
Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report
Recommends suitable sites for selection to participate in trial
Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints)
Uses study tools and management reports available to analyze trial progress
A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. A minimum of 6 years of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines
Proficient in speaking and writing the country language and English. Good written and oral communication skills.Clinical Trial Administration

Local Trial Manager Resume Examples & Samples

University degree or other relevant tertiary education, with relevant working experience and affinity with the legal domain
Minimum of (2 to 6) years of pharmaceutical and/or clinical trial experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Must have a working knowledge of the clinical development process with 2 years of negotiation and contract experience
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, Sarbanes-Oxley,etc.)
Ability to work effectively in cross function teams and able to influence individuals at all levels within multiple organisations
Previous experience working in virtual teams preferred
Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervision
Computer literacy – advanced computer skills and detailed knowledge of a variety of software packages (Microsoft applications like Excel, PowerPoint, and Word …). Able to use a range of computer based systems (e.g. CTMS, internet applications, SharePoint) to track and monitor trial and investigational site-related activities
Excellent communication, negotiation, networking and interpersonal skills. Proficient in speaking and writing the country language and English. Proven track record in contract negotiation and problem resolution.Clinical Trial Administration

Senior Local Trial Manager Resume Examples & Samples

Supervise site/investigator selection process and monitor site performance for assigned country
Partner with the Clinical Trial Assistant (CTA)/Investigator Document Assistants (IDA), Site Manager (SM), Contracts and Grants group and Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols
Represent functional area in divisional/company-wide process initiatives
Support country/site feasibility assessment in conjunction with Lead LTM, CTA/IDA and GTM
Collaborate with the Regional Therapeutic Area Expert (RTAE)/Clinical Program Leader (CPL), GTM and Protocol Owner to select final site list and hold weekly RSM meetings and provides SM training when needed (i.e. for implementation of study amendments/changes in study processes)
Contribute to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates for a single country trial
Create various trial related documents including Country Feasibility Report, Trial Master Spreadsheet and country specific ICF template
Submit requests for vendor services and support vendor selection
Collaborate and review study budget with Global Operations Services and updates budget forecast in CTMS
Review eCRFs/Completion guidelines and participate in EDC User Acceptance Testing (UAT) in conjunction with Lead SM/SM EDC Specialist. Collaborate with Clinical Data Manager (CDM) during analyses to ensure report accuracy and to resolve site specific data issues
Partner with vendors to ensure study supplies are provided to sites and participate in Interactive Voice Response System (IVRS) UAT
Contribute to recruitment strategy and contingency plan in partnership with other functional areas to achieve clinical research targets
Coordinate/present at Investigator Meetings as needed and attend regularly scheduled team meetings and trainings
Track, review and sign-off on SM Trip Reports. Identify trends across the project and escalate to the GTM as needed
Process, review and approve site and local vendor invoices as well as support regulatory requests and ensure appendix 1.4.1 is accurate and complete
Work with SM to ensure Corrective Action Plan is completed for Quality Assurance (QA) site audits and ensure, in collaboration with SM, the timely and accurate data collection, documentation and communication of study progress and issues
Maintain/update the electronic Trial Master File (eTMF), LAF, Trial Master Source and SharePoint and ensure all activities are executed according to internal SOPs/WIs/IFUs and policies
Function as Trial Manager for single country trials as needed and mentor new hires with supervision. Participate in special initiatives as needed
A minimum of a Bachelor's degree or equivalent experience is required. A degree in a Health or Science discipline is preferred
A minimum of 4 years of pharmaceutical experience is required
Prior experience with Neuroscience and/or Immunology Therapeutic Areas preferred
Previous clinical operations experience is preferred
Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, required
Strong computer skills required
Must have strong written and oral communication skills
Minimal travel may be required.Clinical Trial Administration

Senior Local Trial Manager Resume Examples & Samples

Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and GTM. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial
Contributes input to the development of Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial
Maintains and updates trial management systems - (e.g. CTMS, eTMF/LAF, Trial Master Source and Share points). Uses study tools and management reports available to analyze trial progress
Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams
May submit requests for vendor services and may support vendor selection
Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
Reviews and approves site and local vendor invoices as required
Act as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams
Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs Trials
Contributes to optimization of daily processes
Prepares country specific informed consent in accordance with GCO procedural document/templates. Reviews and manages site specific informed consent forms in accordance with GCO SOPs, WIs and applicable regulations
Obtains and maintains relevant local insurance
Acts as a local expert for regulatory affairs to ensure that the trial is in compliance with local regulatory requirements
May also take on responsibility of SM if required
Organizes and ensures IEC/HA approvals and any import/export permits, if applicable
Reviews and ensures completeness and accuracy of “List of investigators” for CSR (appendix 1.4.1)
A BA/BS degree is required. A degree in a health or science related field is preferred
Minimum of 6 years of pharmaceutical and/or clinical trial experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills.Clinical Trial Administration

Trial Manager Resume Examples & Samples

Degree/NVQ 5 or equivalent work related experience
Substantial experience of managing a team and/or trials
Specialist knowledge of appropriate trial governance, systems and processes
Proven ability to develop networks in order to contribute to long term developments
Evidence of ability to explore investigators’ needs and adapt the team accordingly to ensure a quality study is delivered
Evidence of ability to plan the work of a team and study, over extended time periods, reacting to changes in workload and priority
Experience of working in a Higher Education or NHS environment
Experience of collaborations with industry
A commitment to high quality patient and public involvement

Global Trial Manager Resume Examples & Samples

BS or MS Degree, General Science or Life/Health related field with 8 years of experience in managing complex clinical research studies, clinical operations or equivalent
Has a very good understanding of the clinical research and clinical trial management, associated regulatory, processes and quality requirements
Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish
In-country CRA / monitoring/ sites experience an asset
2 years of experience in regional clinical study leadership desirable (field experience)
In depth knowledge of GCPs and ICH guidelines
Solid experience working in teams with a broad range of cultures, including team leadership
The sSDL is able to develop and follow the most efficient operating model for collaborative studies, to
The sSDL is able to manage large & multidisciplinary study team (up to 30 team members) and manages single study with budget that can be >10 M€ with more than 15000 human subjects forstudies
The sSDL may have responsibility for a clinical development sub-program and therefore can be
Accountable and responsible for delivery of study as defined by protocol and according to agreed
As part of his/her development, the sSDL may contribute to a small clinical development sub-program operational strategy and takes the oversight of its delivery
Maintains expertise in GCP and in clinical study management methodology and support process

Local Trial Manager Resume Examples & Samples

Perform regional / local trial management (LTM) including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities
Coordinate and lead the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements
Create, track and report on project timelines
Produce and distribute status, tracking and financial reports for internal and external team members and senior management
Serve as primary back up project contact with Sponsor and internal project team to ensure communication is maintained and reporting schedules are adhered to
Identify out of scope project work. Escalate findings and action plans to appropriate parties
Coordinate data gathering for the development of proposals for new work
Prepare and present project information at internal and external meetings
Coordinate with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes
Undertake clinical project management activities as directed by Clinical Project Manager
Train and may coordinate the work of more junior project support staff
May provide direct site support (SrCRA tasks / on site visits) Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation

Local Trial Manager M/F Resume Examples & Samples

Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial
Works with SM to ensure CAPP is implemented for audits and inspection or any quality related visits
Complies with relevant training requirements
France requirements: A minimum of 4 years of higher education, master 1 level in health or science related field is preferred
Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred
Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills.Clinical Trial Coordination

Senior Local Trial Manager Resume Examples & Samples

Partner with the clinical/internal colleagues to ensure successful execution of clinical trials, while performing trial related activities for assigned protocols
Support country/site feasibility assessment in conjunction with clinical/internal colleagues
Collaborate with the clinical colleagues to select final site list and hold weekly meetings and provide Site Manager training when needed (i.e. for implementation of study amendments/changes in study processes)
Contribute to the Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates for a single country trial
Collaborate and review study budget with Global Operations Services and updates budget forecast in Clinical Trial Management Systems
Review electronic Case Report Form (eCRFs)/Completion guidelines and participate in Electronic Data Capture (EDC) User Acceptance Testing (UAT) in conjunction with clinical/internal colleagues. Collaborate with Clinical Data Manager (CDM) during analyses to ensure report accuracy and to resolve site specific data issues
Track, review and sign-off on Site Manager Trip Reports. Identify trends across the project and escalate as appropriate
Maintain/update the electronic files and ensure all activities are executed according to internal SOPs and instructions to use
Function as Trial Manager for single country trials as needed and mentor new hires with supervision
Participate in special initiatives as needed
A minimum of a Bachelor's degree or equivalent clinical experience is required. A degree in a Health or Science discipline is preferred
A minimum of 4 years of pharmaceutical industry experience is required
Prior experience with Oncology Therapeutic Area is required
Previous clinical operations experience is required
Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required
Minimal business travel (meetings, training, etc.) may be required.4250170309

Global Trial Manager Resume Examples & Samples

Responsible for supporting the operational management and oversight of clinical trials within assigned trials or countries
Oversee the performance of all study ESPs to ensure compliance with study protocol and in accordance with of scope of work
Create global investigator budget and payment schedules as appropriate
Forecast and manage global IMP and clinical study supplies. Works closely with the Technical Operations-Clinical Trial Supply Group throughout the study
Facilitate training sessions (e.g. CRO, monitoring training)
Chair Project Management Team (PMT) meetings to ensure two way flow of information is maintained between the Clinical Trial Team (CTT) and PMT
Assist in the preparation for audits/inspections and implementation of Corrective Actions and Preventive Action (CAPA) plans
May lead Open label, Extension and Long Term Follow up, and small Phase II studies
Bachelor's degree or equivalent University education/degree, preferably in sciences or healthcare
7 years of clinical trial experience with a minimum of 5 years’ experience in leading or managing Phase II and III studies
Experience in executing a wide range of clinical trial activities from study start up to clinical study report
Experience in managing CROs and Technical External Service Providers (e.g. IWRS, ECGs, Central labs) including performance assessments and finance management (e.g. invoices review, change order management, budget reforecasting, RFPs)
Experience in managing a global teams in virtual environment
Excellent decision-making and problem solving skills
Proactively identify and resolve issues
Ability to provide clear directions and instructions

Senior Trial Manager Resume Examples & Samples

Study feasibility and site/lab assessments, providing recommendation of suitable sites for selection to participate in the trial. Ensure appropriate follow-up of pre-trial visit reports
Collaborate with the Clinical Practice Leader (CPL), GTM, country TMs (if applicable), functional management and Protocol Owner to select final site list
Contribute input to the development of the Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for trials to which no GTM is assigned
Lead and coordinate local trial team(s) activities in compliance with SOPs, Work Instructions (WIs) and applicable regulations. Lead project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to, development of trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting
Ensure that all Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within reporting timelines and documented as appropriate
Maintain and update trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and SharePoint sites). Use study tools and management reports available to analyze trial progress
Monitor country and overall study progress (if applicable) and initiate Corrective and Preventive Actions (CAPAs) when the trial deviates from plans and communicates study progress and issues to CPL, GTM, protocol owner and study management teams. Ensure appropriate documentation and follow-up related to protocol issue escalation
May submit requests for vendor services and may support vendor selection. Review and approve site and local vendor invoices as required
May lead and coordinate negotiation of trial site contracts and budgets. May be responsible for forecasts and management of GCO budget to ensure accurate finance reporting and trial delivered within budget. Adhere to finance reporting deliverables and timelines
Conduct trial team meetings and provide or facilitate TM/SM training when needed (i.e. implementation of study amendment and changes in study related processes)
Review and approve Monitoring Visit Reports submitted by SM, which identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and Functional Manager (FM) as needed
Review and approves site and local vendor invoices as required
Work with TMs/SMs to ensure CAPAs are developed and implemented for audits and inspection or any quality related visits
Comply with relevant training requirements
Act as expert for assigned protocols. Develop therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross-functional teams
Act as primary local or multi country contact in GCO for a trial. Establish and maintain excellent working relationships with external stakeholders, such as investigators, trial coordinators, other site staff, key contacts in ED&CP and other internal stakeholders
Actively contribute to process improvement initiatives, and training and mentoring of Site Managers, Clinical Trial Assistants and other TMs
A minimum of a Bachelor’s degree is required, preferably in a Life Science, Nursing, or related scientific discipline
A minimum of 4 years of clinical research/clinical trial experience within the within the Pharmaceutical, Clinical Research Organization (CRO) and/or Biotech industries is required
Prior clinical trial experience in Early Development and Clinical Pharmacology is preferred
Prior experience in the Oncology, Neuroscience and/or Vaccines Therapeutic Areas preferred
Strong knowledge of the drug development process, including International Council on Harmonization (ICH)/Good Clinical Practices (GCP), and local regulatory requirements required
Must have strong leadership skills
Must have good computer skills and be comfortable working with software applications and clinical systems
The ability to work at a fast pace within small exploratory study teams is required
The ability to work on multiple trials in parallel in different disease areas is required
Willingness to travel 50% or more, approximately 2-3 days each week, with overnight stays, is required.7518170410

Global Trial Manager Pre-approval Access Resume Examples & Samples

Considered the program study owner and Pre-Approval Access Program Lead. Main focus is on program management supervision, planning and coordination, including program set-up, execution, and reporting (includes program closure). Measures program progress against agreed upon timelines to milestones
Ensure accurate budget management for assigned programs. This includes ensuring vendors and affiliate budgets are tracking according to plan. Updates are made to account for scope changes
Monitors patient recruitment at the global level, and ensure timely and accurate documentation and communication of program progress and issue escalation
Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the program operates in a constant state of inspection-readiness. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned program utilizing the available tools
In coordination with the Clinical Program Leader, Study Responsible Physician (SRP) and/or Clinical Leader, the GTM is responsible to ensure appropriate program-specific training to the appropriate colleagues
Ensure deliverables are carried out according to the program plan. Provides updates to appropriate Clinical Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of Program status according to Program plan
Strong interaction with the Janssen Medical Affairs, R&D/Operating Company, Clinical Supplies Unit (CSU), QM and external vendor groups
BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy),
Minimum of 5 years clinical trial experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Requires clinical research operational knowledge, project planning/management and communication skills,
Should be flexible and able to manage global or regional teams in a virtual environment
Excellent decision-making and strong financial management skills are essential to this position
Effective leadership skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required.000019RP

Global Trial Manager Resume Examples & Samples

A minimum of a bachelor’s degree is required,
A degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy) is preferred
A minimum of 6 years clinical trial experience in the pharmaceutical industry or CRO is required
Clinical research operational knowledge, project planning/management experience is required
Should be flexible and able to manage global or regional teams in a virtual environment is required
Excellent decision-making and strong financial management skills are essential to this position is required
Strong computer literacy is also required
Strong experience in managing Medical Affairs studies is preferred
May require travel to regional OpCo locations outside Canada – Horsham, PA, Titusville, NJ on an ad hoc basis
Experience in managing RWE/NIS studies (e.g., Registries) Preferred

Senior Global Trial Manager Resume Examples & Samples

Development of specific sections of the protocol and related documents
Development of study tools, guidelines and training materials
Supporting forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholders
Contributing to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards; contributing to the development/amendment of vendor contracts
Implementing issue resolution plans
Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation
Supports the Global Trial Director with the development, management and tracking of the trial level life cycle budget incl forecast, and annual cost targets
Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes. Organize and chair trial sub teams within the scope of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT)
As member of the CTT, contribute to defining the Data Review Plan; participate in data review as specified in the Data Review Plan
May contribute to talent development through active participation in onboarding and training activities. May participate in GDO Trial Management initiatives and working groups
2-4 years of experience in clinical development. Involvement in cross-functional, multicultural and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities
Excellent communication, organization and tracking skills
Proven ability to work either independently or in a team setting, to meet goals by managing compliance, budget and timelines
Proven networking skills and ability to share knowledge and experience amongst colleagues
Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process
Basic knowledge of appropriate therapeutic area

Expert Global Trial Manager Resume Examples & Samples

Responsible for implementation of best practices within Global Clinical Operations and serve as an subject matter expert (SME)
Participate in the on-boarding, mentoring and training of new staff
Bachelor’s degree or equivalent qualification in life science/healthcare required if accompanied with > 4 years’ experience in clinical research
Experience in cross-functional, multicultural and international clinical trial teams and demonstrated capabilities in supporting operational trial activities
Project Managements capabilities required
Proven networking skills and ability to train colleagues
Proven ability to work both independently or in a team setting, including a matrix environment
Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process
Knowledge of principles for trial budgeting
Basic knowledge of Therapy Area preferable

Ex Global Trial Manager Resume Examples & Samples

Contributes to all operational trial deliverables, under the oversight of the (Associate) Global Trial Director, according to timelines, budget, operational procedures, quality /compliance and performance standards. Assigned responsibilities can include but are not limited to
Organization and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee)
Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries)
Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative
Contributing to the creation and execution of an operational risk management plan, highlighting potential risks and actions
Acting as point of contact for all site-related issues and procedural questions
Managing interactions with relevant line functions including data management, drug supply management, clinical development and Novartis Country Pharma Organizations
Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes; can deputize for the (Associate) Global Trial Director to chair and facilitate CTT meetings. Organize and chair trial sub teams within the scope of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT)
As member of the CTT, contribute to defining the data review plan; participate in data review as specified in the Data Review Plan
Contribute to talent development through active participation in onboarding and training activities. May participate in GDO Trial Management initiatives and working groups
Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise, including sharing lessons learned
3-5 years of experience in clinical development with a minimum of 2 years in global clinical research. Involvement in cross-functional, multicultural and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities
Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines

Global Trial Manager Resume Examples & Samples

Bachelor of Science degree or equivalent University education/degree in life sciences or healthcare
Minimum of 7 years' clinical trial experience with a minimum of 5 years' experience in managing Phase II and III clinical trials
Experience in managing complex trials, e.g., Phase III trials, difficult patient populations, managing outsourced trials
Experience in managing External Service Providers (ESPs) including performance assessments and finance management (invoice review, change order management, budget reforecasting, etc.)
Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS)
Experience in managing global teams in a virtual environment
Proven track record for delivering clinical trials within time, budget, and quality expectations
Strong project management expertise
Strong interpersonal, communication (written and verbal) and organizational skill
Self-motivated and able to work effectively in a matrix/team environment
Excellent knowledge of International Council for Harmonization/Good Clinical Practice (ICH-GCP) including international regulatory requirements for the conduct of clinical development programs in key regions (Americas, Europe, Asia Pacific, and Australia)
Fluent in English; fluency in other languages preferred
Advanced computer skills (e.g., Microsoft Office, Word, Excel, PowerPoint)
Available to travel domestically and internationally
Able to demonstrate ownership and initiative
Demonstrated decision-making and problem-solving skills
Work closely with Clinical Development Operations (CDO) group members, e.g., Global Trial Leader, Country Clinical Monitoring Manager, Clinical Research Associates, etc., for trial-related activities at a country/site level (e.g., site initiations, site closures, import/export licenses, TMF, contracts, invoices, ESPs, submission to Health Authorities, ECs/IRBs
Assist and provide input into the Clinical Trial Plan (CTP)
Manage trial activities and ensure delivery of global operational output in accordance with the CTP, timelines, and budget
Ad hoc CDO member at Clinical Trial Team (CTT) meetings
Work closely with cross-functional group (e.g., CTT members, Technical Operations, Clinical Trial Supplies members
Chair Project Management Team (PMT) meetings, ensure a two-way flow of information is maintained between the PMT and CTT, and ensure timely follow-up on agreed upon actions
Ensure adequate trial-specific training of assigned CDO team
Participate in the selection, training, and management of ESPs
Oversee performance of ESPs to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to GTL
Perform review of ESP invoices to ensure that work is performed in accordance with scope of work
Create the global investigator budget and payment schedules as appropriate
Contribute to preparation and/or review of all trial-related documents, (e.g., protocol, monitoring guidelines) in collaboration with other team members
Forecast global supply needs, order supplies, and ensure timely distribution globally (IMP and other materials). Ensure close interactions with Technical Operations-Clinical Trial Supply (TOP CTS) throughout the trial
Organize and supervise preparatory activities for the Investigator meetings, as well as participate and present at the meetings
Contribute to CRA trainings
Perform ongoing quality checks/review of the Study Master File (StMF) and ensure completeness and audit-readiness of the CDO section of the TMF
Ensure trial information is kept up-to-date in Actelion's clinical trial management and documentation
Assume responsibility for other project or trial-related duties as assigned

Senior Local Trial Manager Resume Examples & Samples

Participate in divisional/company-wide process initiatives
Collaborate with the clinical colleagues to select final site list and hold weekly meetings and provide team members training when needed (i.e. for implementation of study amendments/changes in study processes)
Create various trial related documents such as the Country Feasibility Report and country specific ICF template
Plan and review study budget with relevant team members and update budget forecast
Process, review and approve site and local vendor invoices
Review electronic Case Report Forms (eCRFs) and Completion guidelines and participate in Electronic Data Capture (EDC) User Acceptance Testing (UAT) in conjunction with clinical/internal colleagues
Collaborate with Clinical Data Manager (CDM) during analyses to ensure report accuracy and to resolve site specific data issues
Contribute to recruitment strategy and contingency plan in partnership with other Trial Team members
Support regulatory requests as appropriate. Maintain/update all relevant systems (i.e. electronic Trial Master File (eTMF), and Clinical Trial Management System) and ensure all activities are executed according to internal SOPs and policies
Function as Trial Manager for single country trials and mentor new hires with supervision
A minimum of an Associate’s degree or completion of a Nursing program (RN) is required. A Bachelor's degree in a Health or Science discipline is preferred
A minimum of 4 years of pharmaceutical industry and/or clinical trial experience is required
Prior experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines
Experience working with computer software applications required
Good command of English1700177049W

Global Trial Manager Resume Examples & Samples

Accountable for the operational oversight of assigned collaborative studies at an operating company level from start-up (post ReCAP approval) through receipt of the final deliverable and close-out activities and that collaborative studies are conducted in accordance with all applicable regulations/guidelines and applicable Janssen Policies, SOPs and WI’s
Acts as the central contact for designated project communications, correspondence and associated documentation for assigned collaborative studies
Maintains communication with the Collaborative Study Partner and staff during all phases of the collaborative study regarding study progress, issue identification/resolution, contractual matters including payments and collection of required documents
Monitors study progress and initiates corrective and preventative actions when the trial deviates from plans and communicates study progress and issues to collaborative study team members, as required (e.g., Medical Affairs/R&D Study Responsible Physician/Study Responsible Scientist, Collaborative Study Project Lead)
May provide operational input to protocol development, preparation of GCDO Collaborative Study proposal documents and the Request for Service (RFS) process
Ensures that contracts, budgets and payment schedules are prepared in accordance with collaborative study contract requirements and HCC/HCBI considerations
As required, in consultation with appropriate representatives of the operating company, ensures required contract amendments are prepared
Ensures that required safety information (e.g. SAEs/NSAEs, PQCs) are reported and processed per all applicable SOPs/WIs
Accountable for budget oversight for assigned collaborative studies including forecasting. If applicable, ensure that vendors and affiliate budgets are delivered according to plan. Communicates budget discrepancies or payment delays with rationale to Operating Company representatives, including, but not limited to the Project Lead, the Collaborative Studies Lead, Clinical Forecasting & Analytics
Accountable for drug management (e.g. projections, requests) for assigned collaborative studies. May assist in bulk drug forecasts/ordering for collaborative studies programs
For collaborative studies not progressing to agreed contract timelines and/or budget ensures an action plan is implemented and regular status updates are provided to the Project Lead and Collaborative Studies Lead and Study Responsible Physician/Study Responsible Scientist
Maintains documentation of assigned collaborative study in TMF and performs periodic review to ensure accuracy and completeness
Maintain and updates applicable Janssen systems including, but not limited to, mCTMS, TMS, SharePoint, etc. Uses study tools and management reports available to analyze study progress
Develops therapeutic knowledge to support roles and responsibilities
Establishes and maintains excellent working relationships with external working relationships with external stakeholders, investigators, study trial coordinators and other site staff, internal stakeholders, including Medical Affairs and R&D Therapeutic Areas
Contributes to process improvement initiatives and training and mentoring or other collaborative study team members
Participates in preparing for or conducting internal audits or in case of Health Authority inspections
Ensure quality oversight and support of assigned collaborative studies utilizing available tools
May be delegated to act as a Functional Manager for Flex associates within the Collaborative Studies Lead’s portfolio/program
Degree in health sciences, Nursing or related scientific field is preferred
Minimum of 6 year’s clinical research operations experience in the pharmaceutical industry or CRO is required
Experience in managing investigator initiated studies and study types (interventional, non-interventional and/or registries) is preferred
Should have a solid understanding of the drug development process including ICH/GCP and local regulatory requirements
Solid leadership skills are required
Flexible mindset and ability to work in a fast-pace environment is required
Ability to work on multiple collaborative studies in parallel in different therapeutic areas is required
Experience participating and/or managing global, regional, or local teams in a virtual environment is required
Excellent decision‐making and strong financial management skills are essential to this position
Effective leadership skills and proven ability to foster team productivity and cohesiveness is required
Ability to actively participate and contribute to the productivity and cohesiveness of the team is required
Willingness to travel occasionally with overnight stays depending on region is required

Trial Manager Resume Examples & Samples

Provide 1st line technical support for trial users, debug installation problems and assist users in getting systems working
Maintain records of installations, firmware version bugs and other data as required, and by Collecting, collating and maintaining feedback from trial participants
Create and manage test accounts
Manage the distribution of hardware and installation instructions out to trial participants
Manage surveys of trial users, collate the results and generate reports
Arrange engineer appointment for installations
Collect faulty parts from users and engineers as required
Implement firmware upgrades using support tools
Collate information on bugs, faults and defects from trial participants and then cascade fix information to the appropriate resources
Excellent communication skills. (You will represent the professional ‘face’ of Connected Home trials providing first class 1st line support of trial users and some VIPs on the phone or occasionally where necessary by attending in person
Confident with dealing with the British Gas engineering community as well as external customers
Technical – Practical skills with IT (e.g. knows how to set up routers, switches etc), computer literate and able to use Google sheets, able set-up test email accounts, able set up hive equipment and install it. Able to do 1st line technical debugging
Independent and self motivated – (Expected to work without daily guidance)
Prepared to travel to main London office when necessary for meetings
Knowledge of British Gas systems and processes
Basic IT engineering knowledge
Basic Electrical/Electronic knowledge

Trial Manager Resume Examples & Samples

Accountable for the operational oversight of assigned IISs at an operating company level from start-up (post ReCAP approval) through receipt of the final deliverable and close-out activities and that IISs are conducted in accordance with all applicable regulations/guidelines and applicable Janssen Policies, SOPs and WI’s
Acts as the central contact for designated project communications, correspondence and associated documentation for assigned IISs
Maintains communication with the Sponsor-Investigator and staff during all phases of the IIS regarding study progress, issue identification/resolution, contractual matters including payments and collection of required documents
Monitors study progress and initiates corrective and preventative actions when the trial deviates from plans, communicates study progress and issues to IIS team members in support of Medical Affairs/R&D Study Responsible Physician/Study Responsible Scientist
Ensures that contracts, budgets and payment schedules are prepared in accordance with IIS contract requirements and HCC/HCBI considerations. As required, in consultation with appropriate representatives of the operating company, ensures required contract amendments are prepared
Ensures that required safety information (e.g. SAEs/NSAEs, PQCs) are reported and processed according to all applicable SOPs/WIs
Accountable for budget oversight for assigned IISs including forecasting. Communicates budget discrepancies or payment delays with rationale to Operating Company representatives
Accountable for drug management (e.g. projections, requests) for assigned IISs
For IISs not progressing to agreed contract timelines and/or budget ensures an action plan is implemented and regular status updates are provided to the and Study Responsible Physician/Study Responsible Scientist
Maintains documentation of assigned IIS in TMF and performs periodic review to ensure accuracy and completeness
Maintain and updates applicable Janssen systems including, but not limited to, CTMS, TMS, SharePoint, etc. Uses study tools and management reports available to analyze study progress
Develops strong therapeutic knowledge to support roles and responsibilities
Specific therapeutic area experience may be required depending on the position. Should have a solid understanding of the drug development process including ICH/GCP and local regulatory requirements
Solid leadership skills are required. Flexible mindset and ability to work in a fast-pace environment
Ability to work on multiple IISs in parallel in different therapeutic areas is required
Requires clinical research operational knowledge, project planning/management and communication skills
Should have experience with and be able to participate on global, regional, or local teams in a virtual environment
Good analytical skills and solution oriented, actively seeking input from others
Willingness to travel occasionally with overnight stays depending on region.1700179567W

Trial Manager Resume Examples & Samples

May be assigned to oversee Investigator Initiated Studies (IIS), Named Patient Programs (NPP), Post-Trial commitment and Compassionate Use (CU) programs on a local or regional basis as per prevailing SOPs and Work Instructions
5 Ensure accurate budget management for assigned trials. This includes ensuring vendors and affiliate budgets are tracking according to plan. Updates are made to account for scope changes
Ensure compliance with local health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the SMT operates in a constant state of inspection-readiness. Ensure quality oversight of assigned trial utilizing the available tools
In coordination with the Clinical Program Leader, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader, the TM is responsible to ensure appropriate trial-specific training to TCSM and site study staff. Work with country TCSM staff in the set-up and coordination of Investigator Meetings, as applicable
Ensure enrollment commitments meet the projected enrollment across all sites at the clinical trial level, monitors patient recruitment at the study level, and ensure timely and accurate documentation and communication of study progress and issue escalation
Ensure deliverables are carried out according to the trial plan. Provides updates to all SMT and appropriate Clinical Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status according to trial plan
Strong interaction with the medical affairs team /Operating Company, GCDO/RDO functions, Pharmaceutical Development & Manufacturing Sciences (PDMS), QM and external vendor groups, as applicable
4-year University/Bachelor’s degree or equivalent is required. Advanced Degree in a scientific discipline and/or Master Degree is preferred

Global Trial Manager Resume Examples & Samples

Accountable for the operational oversight of assigned collaborative studies at an operating company level from start-up (post ReCAPapproval) through receipt of the final deliverable and close-out activities and that collaborative studies are conducted in accordance with all applicable regulations/guidelines and applicable Janssen Policies, SOPs and WI’s
Monitors study progress and initiates corrective and preventative actions when the trial deviates from plans, communicates study progress and issues to collaborative study team members in support of Medical Affairs/R&D Study Responsible Physician/Study Responsible Scientist
Ensures that contracts, budgets and payment schedules are prepared in accordance with collaborative study contract requirements and HCC/HCBI considerations. As required, in consultation with appropriate representatives of the operating company, ensures required contract amendments are prepared
Establishes and maintains excellent working relationships with external working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff, internal stakeholders, including Medical Affairs and R&D Therapeutic Areas
Minimum of 6 years clinical research operations experience in the pharmaceutical industry or CRO; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Specific therapeutic area experience may be required depending on the position.Should have a solid understanding of the drug development process including ICH/GCP and local regulatory requirements
Proficient in speaking and writing the country language and English language. Good written and oral skills
Should have experience with and be able to participate and/or manage global, regional, or local teams in a virtual environment
Effective leadership skills and proven ability to foster team productivity and cohesiveness
Ability to actively participate and contribute to the productivity and cohesiveness of the team
Willingness to travel occasionally with overnight stays depending on region