FSP Clinical Trial Coordinator
Thermo Fisher Scientific
Description du poste
About the role
We are looking for a Clinical Trial Coordinator to join our global team supporting pharmaceutical and biotech clients. The role provides administrative and technical support to project teams, ensuring audit readiness, site activation, and compliance with SOPs and regulatory guidelines.
Key responsibilities
- Coordinate and oversee assigned trial activities according to the task matrix.
- Perform file reviews (department, internal, country, investigator) and document findings.
- Maintain and update eTMF and Activate systems, ensuring data is current.
- Process documents for client eTMF, conduct eTMF reviews, and distribute communications.
- Assist with site activation, ISF and pharmacy binder preparation, and supply distribution.
- Analyze study metrics, reconcile findings, and support resolution of documentation issues.
- Support feasibility visits (Asia Pac), translation QC, and on‑site regulatory document tracking as needed.
- Proactively communicate risks and support RBM activities.
Required profile
- Experience in clinical trial coordination or related support functions.
- Familiarity with SOPs, client directives, and regulatory guidelines.
- Strong organizational skills and ability to meet deadlines within budget.
- Effective communication with project leads and internal teams.
Required skills
- eTMF (electronic Trial Master File) system usage.
- Activate system proficiency.
- Document management and processing.
- Study metrics analysis and reporting.
- Translation quality control.
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