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Senior Clinical Trial Associate
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Full-time
- Assist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.
- During clinical study team meetings, provides updates on health and currency of study TMF, and document tracking and currency, tracks and maintains cohesive list of protocol deviations.
- supported TMF at intervals specified in project plan and/or applicable SOPs and/or prior to the transition of the TMF to Insmed at end of study.
- Follows up with CROs, and/or functional area representatives on pending/outstanding documentation in accordance with TMF metrics.
- Assists in preparing TMF Health Reports and collecting TMF status updates and TMF metrics
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