Develop and implement GCP-compliant clinical trial management processes to support an efficient sponsor organization * Ensure operational readiness of clinical IT systems (CTIS, EudraVigilance, SPOR), including user management and compliance oversight * Coordinate the development of key study documents such as the Protocol, Investigator's Brochure, SAP, and the Clinical Study Report * Lead CRO and vendor selection processes, including negotiation and contract management * At least 5 years of experience in Clinical Operations / Project Management on the sponsor or sponsor‑representative side * Proven expertise in vendor and CRO management as well as eTMF systems and clinical data processes * Strong project management skills, including budgeting, resource planning, and stakeholder management * A key role in building the Clinical Operations structure with significant room for shaping and decision‑making
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