Senior Manager Clinical Operations (m/f/d)
Fresenius Kabi · Bad Homburg Vor Der Höhe, Hesse, DE
Your responsibilities: - Planning, organization, execution, oversight and evaluation of national and international clinical trials (Phase I-IV, incl. RWE/RWD...
Job description
Your responsibilities: - Planning, organization, execution, oversight and evaluation of national and international clinical trials (Phase I-IV, incl. RWE/RWD) with focus on nutrition clinical studies) according to ICH-GCP, other applicable legislations and internal standard operating procedures (SOPs). This includes the following tasks: - Management of clinical studies (FSMP & Nutrition products) according to target market (EU/US/PhM) requirements - Support in planning of RWE/RWD studies (prospective and retrospective) - Develop detailed project plans, timelines, and budgets estimates for clinical trials and bioequivalence studies - Selection, instruction and supervision of Contract Research Organizations (CROs)/study sites and collaboration with external service providers (e.g. consultants, medical experts) - Cross functional collaboration with central functions (Regulatory Affairs, Pharmacovigilance/Drug Safety, Drug Supply and QA etc.) - Design, development, review of clinical study protocol, CRF and study report, etc - Review of analytical method validation and analysis documents - Support in compilation of regulatory documents, including clinical trial applications (CTAs) and...