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Senior Clinical Trial Manager / Clinical Trial Manager
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- The ideal candidate will possess extensive knowledge of clinical operations, Good Clinical Practice (GCP), FDA regulatory requirements, and previous oncology experience.
- Manage clinical studies and vendors to ensure studies are completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations, International Council for Harmonization (ICH), and GCP guidelines.
- Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, Electronic Data Capture (EDC) providers, and independent contractors) to execute clinical trials.
- Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
- Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.)
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