Your responsibilities:
1. 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:
2. Management of clinical studies (FSMP & Nutrition products) according to target market (EU/US/PhM) requirements
3. Support in planning of RWE/RWD studies (prospective and retrospective)
4. Develop detailed project plans, timelines, and budgets estimates for clinical trials and bioequivalence studies
5. Selection, instruction and supervision of Contract Research Organizations (CROs)/study sites and collaboration with external service providers (e.g. consultants, medical experts)
6. Cross functional collaboration with central functions (Regulatory Affairs, Pharmacovigilance/Drug Safety, Drug Supply and QA etc.)
7. Design, development, review of clinical study protocol, CRF and study report, etc
8. Review of analytical method validation and analysis documents
9. Support in compilation of regulatory documents, including clinical trial applications (CTAs) and amendments
10. Response to queries received from regulatory authorities and ethic committees
11. Ensure compliance to applicable regulatory requirements and standards
12. Monitoring/co-monitoring and supervision of study sites and ensure data integrity and accuracy
13. Set up, review and maintenance of trial master file (e)TMF
14. Safeguarding the study documentation
15. Generation of monthly status reports according to internal reporting system
Your profile:
16. Master’s degree in life sciences, pharmacy, or a related field. Advanced degree (e.g., PhD) is preferred
17. At least 5 years of experience as clinical trial manager (preferably at sponsor end)
18. Experience working with secondary data sources (claims, EHR, registries) highly desirable
19. Hands on experience with project management tools or certification will be preferred
20. Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials and bioequivalence studies
21. Proficiency in Microsoft Office tools. Experience in clinical trial management software is plus
22. Excellent project management skills, including the ability to manage multiple projects simultaneously
23. Ability to work effectively in international teams and matrix organization with multi-disciplinary teams
24. Excellent communication skills, spoken and written (English)