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Sr. Clinical Project Manager
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- The Sr. CPM provides operational leadership to the clinical operations team to ensure project milestones delivery on time, within the budget, high quality and in compliance with the ICH-GCP, Regulatory guidelines and all applicable SOPs/Work Instructions.
- The Sr. CPM should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) utilizing effective communication across organization.
- Provides operations and strategic input and/or approves study documents such as synopsis, protocol, ICF, eCRFs, eCRF Completion Guidelines, Study Plans and Manuals, and Clinical Study Report development, etc.
- Ensure that all aspects of GCP compliance and audit readiness are maintained thought out trial conduct
- Conducts Sponsor quality monitoring/oversight visits to sites and /or CRA performance assessment in adherence to GCP, corporate SOPs and protocol as needed
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