Specialist, Clinical Trials | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This role as a Specialist, Clinical Trials involves providing crucial operational and administrative support for the execution of national and international clinical trials. Day-to-day responsibilities include preparing and processing project documents, ensuring strict adherence to local laws, international guidelines (ICH GCP), and applicable SOPs. You will coordinate essential study documentation, such as the Study Management Plan and Monitor Manual, manage the Trial Master File (TMF) setup and maintenance, and assist in contract negotiations with sites and labs. The ideal candidate holds a Bachelor’s degree (or advanced degree with relevant experience) and possesses practical experience in clinical trial project planning and structuring. Success requires strong project management skills, including analytical thinking, time management, and a proactive approach, enabling the Clinical Operations team to work efficiently and ensuring regulatory compliance.
Required Skills
Education
Bachelor's degree (preferred) or Advanced degree in a related field
Experience
- Professional experience in clinical trials
- Practice in project planning and structuring
- Knowledge and experience in relevant legislation and ICH-GCP guidelines
- Minimum of 1 year of relevant work experience (if holding an advanced degree)
Languages
Additional
- Not specified
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