Clinical Operations Manager (Compliance Focus) | Biologe (m/w/d)
Bionorica SE
Job Summary
This role at Bionorica, a leading German pharmaceutical company specializing in herbal medicines, offers a unique opportunity to combine regulatory expertise with clinical study management. The successful candidate will be responsible for ensuring GCP compliance within Clinical Operations, meticulously maintaining clinical SOPs, and managing deviations and CAPAs. They will also play a crucial role in audits and inspections. Furthermore, the position involves the operational management of clinical studies as the Sponsor Lead, coordinating with external partners, overseeing data integrity, patient safety, and risk management. This position is ideal for a professional with a scientific background and significant experience in clinical trials, seeking a challenging role within a growing, globally active family-owned company that values work-life balance and professional development.
Required Skills
Education
Medical or scientific degree; PhD desirable
Experience
- Extensive professional experience in planning and supervising clinical studies
- Experience in leading study teams
- Experience in managing regulatory topics related to clinical trials
- Experience in clinical monitoring (desirable)
Languages
Additional
- Not specified