Clinical Trial Manager
Clinical Trial Manager
Syneos Health
Rueil-Malmaison, France
Job responsibilities
Project Administration
- Creates and maintains the Trial Master File Management (TMF) Plan. Routinely reviews the TMF to ensure quality, completeness and inspection readiness;
- Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors;
- Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure;
- Assists with identification of and contracting with approved vendors, as necessary;
- Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary;
- Assists with development and implementation of change orders;
- Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently.
Financials/Reporting
- Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones;
- Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management;
- Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting;
- Attends financial review meetings to assist with reconciliation and identification of budget overrun;
- Reviews and approves invoices from sites or vendors and to the client.
Business Development
- Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively;
- May participate in Customer proposal development;
- In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings.
Knowledge/Training
- Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training;
- Develops knowledge of current therapeutic environment.
Qualifications
What we’re looking for
- Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred;
- Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred. CRO and relevant therapeutic experience preferred;
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements;
- Strong organizational skills;
- Strong ability to manage time and work independently;
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade;
- Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment;
- High level of competency in English language;
- Proficiency with MS Office Applications;
- Ability to travel as necessary (up to 25%).
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