Clinical Project Leader Resume Samples

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D Adams

Dee

Adams

6389 Dach Expressway

San Francisco

+1 (555) 372 3388

6389 Dach Expressway

San Francisco

Phone

p +1 (555) 372 3388

Experience Experience

San Francisco, CA

Clinical Project Leader

San Francisco, CA

O'Keefe LLC

San Francisco, CA

Clinical Project Leader

Assisting in the management and development of study start-up documentation
Establish, track and maintain study specific trial management tools/systems (IMPACT)
4 Team work & Attitude, implementation of all new systems necessary for the studies. Support group initiatives in cooperation with other relevant team members
Performing other duties as assigned
Assisting with operational tasks related to site and media activities
Assistance with protocol tests and/or eCRF related questions from sites
Manage and coordinate communications with sites

Philadelphia, PA

Clinical Project Leader and

Philadelphia, PA

Pollich Group

Philadelphia, PA

Clinical Project Leader and

To execute CDMA activities in Japan according to TA-BS strategy that covers preclinical, clinical, PMS and late stages of commercialization
Prepare and/or develop local studies' contents including RMP/PMS plans
Prepare Qualified Document: Contribute to prepare qualified official documents related to science, external and internal regulation (CTD, Educational materials, SOP etc)
Budget control: Adhere to effective cost management according to budget
Provide medical inputs and review of all in- and external documentation
Ensure Ethical/Safety: Ensure NBI provides safety and contribute to benefit/risk evaluations of products
Ensure ethics and compliance

present

Detroit, MI

Associate Director, Clinical Project Leader

Detroit, MI

Nicolas-Yost

present

Detroit, MI

Associate Director, Clinical Project Leader

present

Direct the creation and execution of clinical trial activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
Builds and leads cross functional clinical study team to achieve study milestones
Interact with internal and external groups to achieve study milestones
Manage clinical study budgets within agreed variance
Communicate clinical studies performance data to members of the management and scientific team
Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report
Provides input into the clinical development strategy for assigned programs; including but not limited to, operational feasibility, budget and timeline estimates

Education Education

Bachelor’s Degree in Clinical Trials Research Related Curriculum Plus

Rowan University

Bachelor’s Degree in Clinical Trials Research Related Curriculum Plus

Skills Skills

Ability to work in group setting and independently; ability to adjust to changing priorities
Ability to project and maintain a professional and positive attitude
To report and keep his/her immediate Manager informs about his/her business progress and assisting him/her to be able to build the yearly operating plan
Strong organizational skills
Strong interpersonal and communication skills, both verbal and written
Excellent attention and orientation toward meticulous work
Interacts with all customers appropriately and professionally
Represent the Company in a professional manner and with the highest integrity
To ensure that all EMEA current Business Ethics, Regulatory and Quality procedures are followed
Management skills relating to projects, human resources and time

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Clinical Operations Project Leader Resume Examples & Samples

Successfully manage cross functional team to deliver on registry milestones
Report on registry milestones and activities to Senior Management
Define mid- and long-term strategy of the registries with internal stakeholders
Actively engage international KOLs in the successful conduct of the registries
Identify, evaluate, retain and oversee contract research organizations, contribute with the selection and management of contractors and third parties for work conducted within registries
Plan and implement resource allocations (both people and financial) to the individual projects and activities of the department in collaboration with the Registry Team Lead. Assure effective resource utilization in line with the department priorities
Support scientific content output (abstracts/manuscripts/posters) from registries
Work with other than R&D functions on strategies for supporting products during their life cycle, identifying research to support sales and ensuring its execution
Develop standard global processes and procedures to support registries practices
The position will require up to 10-20% travel domestic and international
Bachelor’s degree in scientific field required. Advanced degree desired
Strong track record of significant biopharmaceutical experience in clinical research and/or non-interventional studies and project management
Successful Leadership/management experience with leading a cross/functional team is required. Demonstrated ability to manage and mentor staff
International experience in large organizations and complex operational, project management and execution and knowledge of the CRO industry is a strength
Broad and deep knowledge of ICH/GCP, GPP and FDA/EMA regulatory requirements
Ability to communicate a sense of purpose, and motivate the team to think strategically is essential
Operational experience with managing a budget and effective resource management is required
Excellent interpersonal and presentation skills, as well as proven ability to evaluate, interpret and present complex scientific and clinical data is required

Clinical Trials Project Leader Resume Examples & Samples

Appropriately exhibits persuasive communication skills to enhance the likelihood of building commitment and buy-in
Establishes, builds, and fosters relations with influential decision makers both internal and external
Conveys difficult information diplomatically
Exhibits ability to adapt communication style and approach to circumstances, particularly when addressing concerns or proposing a solution
Identifies and follows through on opportunities for self-improvement
2-4 years recent clinical trials project management experience to include: addressing project forecasting, identifying complex changes, developing scope of work, leading and managing out of scope changes leading negotiation conversations with sponsors independently, developing and managing project budget, and collaborating with faculty and other functional groups
Broad range of therapeutic areas experience
Experience in a service organization including Clinical Research Organization or vendor
Clinical background a strong plus
Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or 2. Completion of a master’s degree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or 3. Completion of a bachelor’s degree plus a minimum of four years directly related experience in clinical trials research; or 4. Completion of a bachelor’s degree plus a minimum of five years closely related research experience

Project Leader, Clinical Operations Resume Examples & Samples

Completion of an allied health degree (e.g., Respiratory Therapy,
Completion of a master’s degree in Public Health, Health Administration or a
Completion of a bachelor’s degree plus a minimum of three years directly related
Completion of a bachelor’s degree plus a minimum of four years closely related research experience

Associate Director, Clinical Project Leader Resume Examples & Samples

Direct the creation and execution of clinical trial activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
Ensure compliance of clinical trials with national and international regulatory requirements; overall data quality and integrity; and human subject protection
Builds and leads cross functional clinical study team to achieve study milestones
Interact with internal and external groups to achieve study milestones
Determine study requirements, define specifications, and initiate and lead the selection of third party vendors
Manage CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon time, budget and quality
Manage clinical study budgets within agreed variance
Communicate clinical studies performance data to members of the management and scientific team
Prepare and maintain required study and regulatory documentation, e.g., reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual, Investigator Agreements and budgets
Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report
Provides input into the clinical development strategy for assigned programs; including but not limited to, operational feasibility, budget and timeline estimates
Set program level standards and best practices to ensure consistent execution and delivery across studies
Participate in and/or lead departmental initiatives
Conducts lessons learned exercises to provide continuous process improvement and sharing of best practice
Executes the project management process and the deliverables linked to this process. This includes planning, directing and coordination, organizing, staffing, and controlling related to the project management process
Manages the operational components of the clinical study in its entirety including planning, resourcing, timelines, quality control, and financial management
Reports project information to the applicable stakeholders (e.g. data management, program managers)
Preferably ten years of clinical operations experience and a thorough understanding of cross-functional clinical processes including site management and monitoring, drug supply, data management, biostatistics, medical writing, medical monitoring, drug safety, and regulatory affairs in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues
Leadership, project management, resource management, administrative and technical capabilities are required
Effective verbal and written communication skills are required in relating to customers and colleagues both inside and outside the organization
Knowledge of team development principles and successful implementation required
Experience of managing multiple studies including extensive experience in the management and oversight of CROs is key. A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
Ability to effectively lead a cross-functional team in a matrix environment
Excellent interpersonal, influencing and negotiation skills
Proven problem solving and timely decision making skills
Excellent leadership, risk management, planning and project management skills
Management and oversight of CROs
Ability to effectively interact with all levels of professionals and support staff
Ability to lead one or more initiatives to facilitate operational efficiency
Ability to lead all activities for an indication or program
Is cool under pressure and takes unpopular stands as necessary
Effectively leads change and actively risk manages delivery
Thorough knowledge of global regulatory and ICH/GCP guidelines essential
Financial and business acumen - forecasting, budgeting, resourcing
Ability to work across regions and functions
Excellent communication, interpersonal, and people management
Facilitative leadership, delegation and prioritization skills
Strong judgment and risk assessment
Ability to anticipate potential future impacts

Manager, Clinical Project Leader Resume Examples & Samples

Excellent interpersonal and communication skills (verbal and written), including proficiency in medical terminology
Professional demeanor with ability to interact effectively with scientists and managers from multiple disciplines; serves to provide internal operational expertise on assigned area and liaise with external organizations specific to clinical trial
Strong organizational and time management skills. Self-motivation and attention to detail

Clinical Project Leader for Cras Resume Examples & Samples

Assist in providing overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s)
Support Project Management and functionally oversee CRAs across all therapeutic areas to ensure business priorities are achieved
Allocates workload to ensure optimal productivity, alignment with the priority projects and optimal usage of RCRA staff. Ensures that monitoring activities within the assigned area are in compliance with GCPs, ICH Guidelines, SOPs and project requirements
Ensures that monitoring activities within the assigned area are in compliance with GCPs, ICH Guidelines, SOPs and project requirements. Liaises with Clinical Project Leaders (CPL) and Medical Advisors (MAs) to ensure support of project and monitoring activities
Develops and implements monitoring standards that are consistent across projects and geographic areas
Reviews samples of site visit reports with regard to company SOPs and worldwide guidelines for monitoring visit reports. Ensures appropriate training or corrective action as warranted
As part of the overall CPL group - conduct Quality control visits (QCVs) at the request of the project CPL. Communicates findings to project CPL and other team members and management as appropriate and per SOP instructions
Conduct QCVs when possible for new CRAs or CRAs with any potential quality or milestone deliver concerns. These QCVs can be arranged in conjunction with CPL to account for the QCV study target or can be over the target amount as necessary
Regular review of study metric reports (Monitoring visits, Monitoring Report Reviews & associated timelines, site specific issues and escalations tracking, site IMPACT compliance) to ensure on time and high quality delivery of studies
Work in conjunction with appropriate vendor Clinical Research Manager (CRM) to address CRA performance concerns
Bachelor’s degree + 6 years of experience in the pharmaceutical industry or clinical-related discipline (e.g. investigative site) including at least 5 years of direct clinical trials experience
Familiarity with medical terminology, general understanding of R&D process and previous exposure to GCPs/ICH is required
Capable of interacting effectively, with minimal support, with Investigators, Trial Operation stakeholders (CTOM/CSD), RCRAS and other associates within and outside CSU; may be required to assist the CPL in providing internal operational expertise on assigned area and liaise with external organizations specific to the clinical trial; may be required to provide local vendor oversight (IRB, Clinical supplies, etc), or to assist CPL in this function
Demonstrated strong leadership potential (trial management experience, Lead CRA experience, etc.)
Strong presentation skills (Powerpoint)
Professional demeanor with ability to interact effectively with investigators and managers from multiple disciplines
Ability to proactively identify and propose solutions to operational activities
Decision-making and problem-solving skills
Ability to work autonomously and to efficiently & effectively provide status reports to support the CPL
Ability to anticipate and timely escalate issues and to define appropriate action plans
Ability to work effectively on a team and foster team spirit and team motivation (team work)
Ability to work in a multiplatform environment (Study Start Up, IP, Safety & Trial Ops)with internal and/or external partners (CROs etc)
Ability to co-manage [manage] and co-lead [lead] study meetings (Investigator / SC meetings, expert meeting, CRA Teleconferences, etc.)
Ability to adapt and be flexible to change and managing internal and external obstacles
Self-motivated, detail-oriented, ability to handle multiple tasks and to prioritize. Ability to manage
Complex or uncommon tasks with appropriate level of supervision/ training/coaching
Familiarity with Windows-based computer applications (eg, MS EXCEL, ACCESS and Powerpoint) and working in clinical trial management systems (eg, IMPACT)

Clinical Project Leader Resume Examples & Samples

Working knowledge of clinical study development, FDA regulations and ICH/GCP guidelines
Operational planning experience
Strong organizational and time management skills. Self-motivation and attention to detail. #LI-SA

Senior Manager, Clinical Project Leader Resume Examples & Samples

Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s)
Interface with corporate CTOMs, CRA Team, MAs and CSDs for operational input for feasibility, trial design/methodology, standard medical practice and data capture
Develop and manage the trial budget. Overall responsibility for negotiation of financial aspects of clinical trial
Collaborate with medical function in the safety evaluation of study subjects in ongoing trials
Ensure all aspects of study site management i.e. recruitment of qualified investigators, site initiations, conduct investigator meetings, ensure enrollment criteria are met and other aspects of the study management as appropriate
Responsible for mentoring and team cohesion. CPL mentoring as needed
Facilitate development of study tools and appropriate tracking systems for coordination of trials, grants, enrollment status and clinical supplies. Ensures adherence to contractual obligations of local vendor relative to the service provided, as appropriate. Contribute to operational details in specifications for local vendor contracts, as needed
Ensures Lessons Learned are shared among the CPL department, as well as looks for opportunities for process improvement and efficiency
Bachelor’s degree and 10 + years of industry experience including 8+years of clinical research experience
1-2 years of field monitoring experience; and in addition 2 or more years of prior experience as a manager in a pharmaceutical setting
Working knowledge of clinical study development, FDA regulations and ICH/GCP guidelines. Operational planning experience

Project Leader, Clinical Operations Resume Examples & Samples

3-5 years recent clinical trials project management experience to include: addressing project forecasting, identifying complex changes, developing scope of work, leading and managing out of scope changes, leading negotiation conversations with sponsors independently, developing and managing project budget, and collaborating with faculty and other functional groups
Broad range of therapeutic area experience
Clinical background also strong plus
2+ years of observational research experience
Pediatric research experience
Background in Public Health

Clinical Project Leader Resume Examples & Samples

Demonstrate leadership, organization, and positive attitude to project team members, clinical operations colleagues, and management
Simultaneously design, start up and manage multiple clinical projects within approved timelines/budget
Develop and maintain partnerships with CRO’s, clinical vendors and investigators
Liaise with CRO and clinical sites to monitor study progress
Develop project plans and make decisions regarding daily study management/ compliance, pro-viding guidance for CROs
Act as primary liaison with all internal and external partners regarding clinical projects
Research and develop protocol designs and clinical FDA submission strategies; liaise with key opinion leaders, statisticians and consultants, as needed, to accomplish
Compose/ review study documents. (e.g. protocol, investigator’s brochure, source documentation, CRFs, informed consents, IRB submissions, project timelines, site selection questionnaire, Monitoring Plan, Communications Plan, Serious Adverse Event Plan, Statistical Analysis Plans, Data Management Plans, Edit Checks, and Clinical Study Report Shells)
Coordinate investigator meetings and conduct presentations
Supervise the collection of regulatory documents and maintain project files
Supervise the ordering, packaging, and shipping of clinical drug; maintain accountability logs
Maintain trial tracking spreadsheets, including enrollment, monitoring visit schedules, document tracking, tracking of drug and CRFs, etc; Track Key Performance Indicators
Ensure trials are properly monitored in accordance with GCP, FDA regulations and SOPs; Review CRO/auditor monitoring/audit reports and conduct co-monitoring or audits as needed
Develop systems to increase and assure study compliance
Analyze costs incurred vs. budgeted costs; Implement ways to decrease costs
Prepare and liaise with investigator sites for FDA Inspections
Review and assure quality of clinical study reports
Respond to FDA requests for clarification
Provide positive and constructive feedback for CROs, potential partner companies, and potential department colleagues in order to build better projects and teams
Update investigator database to assess compliance risk for future site selection
Create and update Departmental SOPs
Promptly forward SAE reports to Regulatory Affairs for FDA submission; Follow-up with CROs and/or investigators for additional info on SAEs and request hospital records, when necessary
3-4 years of clinical project management experience in a similar role
Prior experience as a Clinical Research Associate with CCRA certification is a plus
Demonstrated knowledge and mastery of ICH, GCPs, applicable U.S. Federal Regulations, Clinical Research, ANDAs, NDAs

Clinical Project Leader Resume Examples & Samples

Minimum of 3 to 5 years of experience as a Clinical Research Associate
Management skills relating to projects, human resources and time
Strategic thinking, negotiation as well as oral and written communication skills
Leadership and team spirit
Intermediate knowledge of Microsoft Outlook
Intermediate knowledge of Microsoft Word
Intermediate knowledge of Microsoft Excel
Intermediate knowledge of Microsoft PowerPoint
Beginner knowledge of required databases

Clinical Trials Project Leader Resume Examples & Samples

Completion of a master's degree in Business Administration, Health Administration, Public Health or a related area with 3 years directly-related experience managing multi-center clinical trials; or
Completion of a bachelor's degree plus a minimum of 5 years directly related experience managing multi- center clinical trials
Completion of a bachelor's degree plus a minimum of 6 years closely related research experience OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION OR EXPEREINCE
State of North Carolina license may be required**
Successful candidates generally have a minimum of 5 years of experience in the following areas: Clinical research management: Operational understanding of a broad set of research processes and guidelines, including study design, methods, data, and relevant FDA and HHS regulations and guidelines
Multidisciplinary (multiple levels of same type or cross-functional) team management: Experience delegating tasks
Financial management: Operational understanding of the common components of a budget
Budget projections
Writing Skills
Capability of conducting literature searches
Software knowledge: Microsoft Windows Microsoft Word Microsoft Excel Microsoft PowerPoint Microsoft Project or equivalent project management software Microsoft Access, desirable

Project Leader Academic & Clinical Programs Resume Examples & Samples

Manage all day-to-day activities of both programs, including managing project files and databases, stakeholder priorities, project activities, meeting preparation and participation
Determine project goals, plan schedule of deadlines, assign tasks, and develop action plan and processes from inception to evaluation
Prepare or participate in the preparation of abstracts, research reports, funding proposals, operations and procedure manuals, and other written material and documentation as required
Build relationships across Baylor College of Medicine, residency programs
Expertise and experience in project management, medical education, and clinical service lines
Technological proficiency with learning management system software, Blackboard LCMS, e-learning content creation
Outstanding interpersonal skills and communication skills required and must be able to work independently as well as demonstrate the ability to work collaboratively in a team to meet deadlines
Detail oriented, strong organizational, efficiency, and prioritization skills
Ability to display a positive attitude and high degree of flexibility

Clinical Sciences & Operations Project Leader Resume Examples & Samples

Ensures appropriate communications channels are maintained and reporting schedules adhered to. Key relationship manager for the program
Responsible for providing input into the operational strategy and accountable for adapting operational plans, with input from all applicable functions within the CSO, in order to propose the optimal clinical operations solutions and scopes of work that creates the most value for the project, team and the platform
Builds a strong relationship with the project team, platform team and key stakeholders
Develops and negotiates study/program budgets, timelines and other expectations in order to establish clear expectations. Accountable for financial oversight of the project/program. Re-negotiates when required
Responsible for routine reporting of the project’s status to the team & platform
Responsible for assessing the impact of the project for the platform
Accountable for ensuring the study/program performance within the CSO and for driving the multi-disciplinary CSO project team according to project requirements & defined project objectives in order to create the most value for the project
Transmits clear project requirements to the CSO functions
In conjunction with the function leads within the CSO, builds study teams that are adapted to meet project’s needs/requirements
Sets team goals and provides performance reviews for the team performance
Lead CSO Operational Project Team meetings to address status (operational, budget & resource) and critical issues
Foster a true, business minded, customer-oriented atmosphere and skill set for the project team allocated across functions
Develop and implement continuous improvement for assigned projects to ensure the quality of the deliverables
Oversight and accountable for project performance to ensure it meets the project expectations as far as timelines, quality and budget. Makes adjustments to the plan and/or team as required
Anticipates project risks and develop and implement risk management plans to minimize negative impact in fulfilling project deliverables
Lead development of phase transition plans for project
Supervise maintenance of the project management information and tracking
Represents CSO when collaborating and goal setting with other platforms and enabling functions in order to successful meet the requirements of project
Lead the discussion on the choice of vendors for outsourced programs and providing input into vendors used for specific activities and is accountable for deliverables for full-package outsourcing
Contribute to CSO business expansion and to develop the CSO catalogue for services
Identify opportunities for improving organizational processes to continue to drive organizational excellence
Bachelor’s degree in relevant scientific and/or medical field
Minimum of 8 years’ experience in clinical research in pharmaceutical industry
Transversal and strategic leadership capabilities
Serves as internal consultant and primary liaison with all groups outside of the CSO platform for projects
Excellent organizational, interpersonal and communication skills (verbal & written)
Capability to effectively handle large complicated global projects that integrate various disciplines
Ability to driver decision making process
Ability to see and manage expectations
Self- motivated, results driven, detail-oriented and good organizational skills

Project Leader, Clinical Trials Dcri Resume Examples & Samples

Follow established guidelines in the collection of clinical data and administration of clinical trials
Assist in the determination guidelines for new protocols
Assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies, contribute to the ongoing analysis and modification of protocols
Recommend amendments to study protocols as appropriate
Confer with site coordinators and physicians to explain protocol and elicit compliance with regulations
Assure adherence to Federal Drug Administration and protocol guidelines
Identify potential problems and/or inconsistencies and take action as appropriate
Coordinate and lead the work of the research team and provide feedback to staff supervision on a routine basis
Participate in conjunction with the principal investigator in the final negotiations of trial budget and contract
Prepare a variety of narrative and analytical reports, documents, and correspondence for contracting agencies, team members, participating departments and senior management regarding trial status
Recommend corrective action as necessary
Perform other related duties incidental to the work described herein
Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) plus a minimum of six years healthcare experience; or
Completion of a bachelor's degree plus a minimum of five years closely related research experience. **State of North Carolina license may be required.**

Clinical Trials Project Leader, Dcri-outcomes Resume Examples & Samples

Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or
Completion of a master's degree in Public Health, Health Administration or a related area with one year directly related clinical trials research experience; or
Completion of a bachelor's degree plus a minimum of four years closely related research experience

Clinical Trials Project Leader Resume Examples & Samples

Completion of a master's degree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or
Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or
Completion of a bachelor's degree plus a minimum of five years closely related research experience

Clinical Project Leader and Resume Examples & Samples

To execute CDMA activities in Japan according to TA-BS strategy that covers preclinical, clinical, PMS and late stages of commercialization
Maximize Product Values: Prepare local Integrated Brand Plan (IBP) considering Japan specific needs, together with Marketing and related functions
Prepare Qualified Document: Contribute to prepare qualified official documents related to science, external and internal regulation (CTD, Educational materials, SOP etc)
Develop CDP: Make contributions to the Clinical Development Protocol (CDP) based on medical needs, TA strategy and insights obtained from FBMA
Ensure EEE: Ensure external expert engagement according to IBP and coordinate scientific meetings such as advisory board and luncheon seminars in congress
Ensure Ethical/Safety: Ensure NBI provides safety and contribute to benefit/risk evaluations of products
Budget control: Adhere to effective cost management according to budget

Clinical Trials Project Leader, Dcri-outcomes Resume Examples & Samples

Completion of an allied health degree (e.g., RespiratoryTherapy, Radiologic Technology, Licensed Practical Nurse) or Associatesdegree in Clinical Trials Research related curriculum plus aminimum of five years healthcare experience; or
Completion of a master's degree in Public Health, HealthAdministration or a related area with one year directly relatedclinical trials research experience; or
Completion of a bachelor's degree plus a minimum of threeyears directly related experience in clinical trials research; or
Completion of a bachelor's degree plus a minimum of four yearsclosely related research experience

Clinical Project Leader Resume Examples & Samples

Review clinical investigation plan, patient documentation and case report forms, presentation of study to potential investigators, submission to local authorities, ethical committees and hospital/clinic administrative services, contractual issues incl. investigator’s, follow-up of recruitment progress, payments, and data collection and proceeding progress in co-ordination with Data Management unit
Prepare all documentations requires for submission to local authorities, ethical committees to evaluate a project
Ensure that reportable SAE's are reported according to company and local regulatory requirements
Participation to international clinical studies, monitoring the quality and results in accordance with the protocol under co-ordination of Clinical Managers
Help in identifying site/protocol trends to execute adequate action plans
Budget, define cost and help to identify resources needed for study implementation
Logistic and technical expert support to clinical department, attendance to patients’ follow-ups, collection of technical and clinical data on CRFs on site, ensure to achieve the enrollment plans
Supports physicians during the enrolment and follow up phase of clinical studies. Detect and escalate any issues related to the study site, in a systematic and timely manner. Design, propose and implement actions plans to address identified issues
Train sites in CRF's completion as well as how to answer to queries correctly and the relevance and their responsibility to provide a timely response to queries
Frequent travel to visit investigational centers (Local and foreign countries) and to attend meeting with project team and/or operational/functional organization
Budget ensures payments are done according to contracts
Administrative task related to the successful progress of the study under supervision of Clinical Managers with other involves CRAs or CFEs
University degree preferably in life health sciences
Fluent in English, as well as the local language (and third language) if possible
Previous experience in project management in Clinical investigation in pharmaceutical industry, medical device or CRO
Computer knowledge
Ability to travel domestically and internationally and have a valid driver’s license

Project Leader, Clinical Trials Dcri Resume Examples & Samples

Completion of an allied health degree (e.g., Respiratory Therapy,Radiologic Technology, LicensedPractical Nurse) plus a minimum of seven years healthcare experience; or
Completion of a master#s degree in Public Health, HealthAdministration or a related area withthreeyears directly related clinical trials research experience; or
Completion of a bachelor's degree plus a minimumof five yearsdirectly related experience inclinical trials research; or4. Completion of a bachelor's degree plus a minimum of six yearsclosely related research experience
State of North Carolina license may be required
EXPERIENCE

Clinical Trials Project Leader Resume Examples & Samples

Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) plus a minimum of five years healthcare experience; or
Completion of a master’s degree in Public Health, Health Administration or a related area with one year directly related clinical trials research experience; or
Completion of a bachelor’s degree plus a minimum of three years directly related experience in clinical trials research; or
Completion of a bachelor’s degree plus a minimum of four years closely related experience

Clinical Project Leader Resume Examples & Samples

7. Help in identifying site/protocol trends to execute adequate action plans
8. Budget, define cost and help to identify resources needed for study implementation
2 Site Management
1 Logistic and technical expert support to clinical department, attendance to patients’ follow-ups, collection of technical and clinical data on CRFs on site, ensure to achieve the enrollment plans
2 Supports physicians during the enrolment and follow up phase of clinical studies. Detect and escalate any issues related to the study site, in a systematic and timely manner. Design, propose and implement actions plans to address identified issues
3 Perform stand duty
4 Train sites in CRF's completion as well as how to answer to queries correctly and the relevance and their responsibility to provide a timely response to queries
5 Frequent travel to visit investigational centers (Local and foreign countries) and to attend meeting with project team and/or operational/functional organization
6 Budget ensures payments are done according to contracts
7 Administrative task related to the successful progress of the study under supervision of Clinical Managers with other involves CRAs or CFEs
3 Problem solving & innovation this job requires that the incumbent identifies and analyses problems, makes timely proposals for solutions and decisions. Discuss them with management
4 Team work & Attitude, implementation of all new systems necessary for the studies. Support group initiatives in cooperation with other relevant team members
5 Customer Orientation & Communication, Main point of contact for the study. Efficiently communicate expectation to the site and get agreements in critical points. Communicate effectively with all members of the team locally, globally and with the investigator sites
6 Performance Development, develop personal and technical skills in line with the Curriculum map and with the aid of the supervisor. Examples are communication, interpersonal, presentations skills, and medical knowledge of therapeutic areas as necessary. Attend company and external meetings and symposiums as appropriate and present the affiliate

Clinical Trials Project Leader, Ctsi Resume Examples & Samples

Ensure projects are conducted in compliance with applicable regulatory requirements and institutional standards
Conduct regular meetings with project team, facilitate team meetings, effectively communicate relevant project information to CTSI leadership, and communicate difficult/sensitive information tactfully. Identify operational problems, issues, obstacles, barriers, and lessons learned across the assigned projects and make recommendations to CTSI leadership regarding solutions and process/system improvements
Provide oversight for delivery of project objectives. Serve as a resource to faculty and laboratory staff in identifying and accessing the appropriate complement of resources and support needed to achieve their goals, identify potentialobstacles, and collaboratively solve emerging problems. Ensure project documents are complete, current, and stored appropriately
Prepare status reports and track desired metrics for inclusion in periodic progress reports
Ensure appropriate legal and procurement documents are in effect
Work closely with CTSI Finance to monitor and forecast expenditures, ensure timely and accurate invoicing, and monitor receivables for projects
Work closely with the CTSI Grants Manager to ensure compliance with institutional, state, and federal policies. Develop and Coordinate Pilot Funding Programs: Develop and coordinate assigned pilot funding programs. This includes developing the application solicitation and submission process, coordinating the review process, ensuring all subcontracts and regulatory approvals arein place, monitoring progress, and reporting outcomes to the PI, funding agencies, and/or other key stakeholders. Contribute to improvements of systems, tools, and processes used in project management practices (timeline, financial, reporting, project communication, and review standards) for translational initiatives across the CTSI
Strongly prefer candidates with experience in Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) Strongly prefer candidates with grant writing experience Strong analytical and writing skills Strong interpersonal, communication, and presentation skills Ability to manage competing and changing priorities and multiple tasks under inflexible timelines An individual who will be successful in this position should bring refined hands-on laboratory experience, direct experience developing in vitro and in vivo models for drug development, and direct experience in and a good working knowledge of early translation into the clinical setting

Clinical Project Leader Resume Examples & Samples

Initiate and follow up clinical trials at the investigators
Select the appropriate sites to conduct Abbott trials
Be responsible for study clearance : submission to EC and/or CA when applicable
Supervise study start up : contracts finalization and site initiation
Conduct regular visits at investigation centers to ensure compliance to study and quality of data collection
Help with implantation and follow up of the requirements in the framework of the studies
Assistance with protocol tests and/or eCRF related questions from sites
Support cases or FU to ensure proper utilization of devices in the frame of the study
Ensure all administrative, legal and regulatory steps are taken correctly, in compliance with national regulations and internal SOPs
Manage and coordinate communications with sites
Liaise with other clinical groups: CRA/FCRA/Study managers, to ensure proper overview on clinical activity at sites
Maintain and develop a network of Key Opinion Leaders on a clinical basis, audit the centres to ensure they are in line with good clinical practice, influence the choice of investigator centres