Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and project timelines. Where applicable, act as a Country Lead for projects with no regional Lead assigned.
Perform regulatory, start‑up and maintenance activities according to applicable regulations, SOPs and work instructions.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Review, prepare and negotiate site contracts and budgets with sites, if applicable.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project‑specific information.
Ensure contracts are fully executed, regulatory documents and approvals are granted, IP ...