Senior Clinical Trial Coordinator – Clinical Operations
Thermo Fisher Scientific
Description du poste
About the role
Thermo Fisher Scientific is seeking a Senior Clinical Trial Coordinator to support the delivery of global clinical studies. The role provides operational and administrative expertise, ensuring trial activities are executed on time, within budget, and to high‑quality standards.
Key responsibilities
- Coordinate and oversee assigned clinical trial activities in line with project requirements.
- Maintain inspection‑ready electronic Trial Master Files (eTMF) and perform regular quality checks.
- Support clinical systems such as eTMF, GoBalto, and other study‑management platforms.
- Assist with Risk‑Based Monitoring (RBM) activities and study administration tasks.
- Organise meetings, prepare agendas, and document minutes.
- Manage local regulatory documentation, submissions to IRBs/IECs, and vendor coordination.
- Prepare and distribute Investigator Site Files, pharmacy binders, and study supplies.
- Support translation activities and quality‑control reviews.
- Participate in study start‑up meetings and mentor new team members.
Required profile
- High school diploma or equivalent (bachelor’s degree preferred).
- Approximately 4+ years of experience in clinical research, clinical operations, or clinical trial coordination.
- Strong organizational skills and ability to work across multiple functions.
Required skills
- Experience with electronic Trial Master Files (eTMF) systems.
- Familiarity with GoBalto or similar study‑management platforms.
- Knowledge of Risk‑Based Monitoring (RBM) processes.
- Document processing and vendor tracker management.
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