Senior Clinical Study Manager
Job Summary
To support clinical programs in cell/gene therapy and oncology, the contract Senior Clinical Study Manager will manage day-to-day study execution, ensuring compliance with ICH-GCP and FDA regulations, while working remotely on a full-time basis.
Key responsibilities
- Manage and oversee clinical study activities to ensure compliance with GCP, ICH, and FDA regulations
- Coordinate with CROs, vendors, and site teams to ensure timely progress of clinical trials
- Prepare and review study documentation, reports, and progress updates
Required qualifications
- University/college degree (BS/BA/MS) or certification in a related health profession
- 8 - 10 years' experience, including 4 - 5 years in a pharmaceutical setting
- Previous study management experience with at least 4 - 5 years of relevant experience
- Experience in Cell/Gene Therapy and Rare diseases; recent Oncology experience is desirable
Complete Job Description
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