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Perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines. May also include maintenance activities.
Key Responsibilities:- Serve as Single Point of Contact (SPOC) for assigned studies, coordinating between investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to SOPs, Work Instructions (WIs), quality of deliverables, and project timelines.
- Initiate start-up and site activation processes according to applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project teams.
- Prepare comprehensive site regulatory documents, reviewing for accuracy and completeness.
- Evaluate site performance metrics, providing actionable feedback to management.
- Review, establish, and agree on project planning and timelines. Implement contingency plans as needed to ensure smooth project execution.