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Senior Manager Clinical Operations (mfd)
Job Location:
Monthly Salary:
Posted:
3 June 2026 (30+ days ago)
Posted:
Application Deadline:
31 August 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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 amendments
- Response to queries received from regulatory authorities and ethic committees
- Ensure compliance to applicable regulatory requirements and standards
- Monitoring/co-monitoring and supervision of study sites and ensure data integrity and accuracy
- Set up review and maintenance of trial master file (e)TMF
- Safeguarding the study documentation
- Generation of monthly status reports according to internal reporting system
Your profile:
- Masters degree in life sciences pharmacy or a related field. Advanced degree (e.g. PhD) is preferred
- At least 5 years of experience as clinical trial manager (preferably at sponsor end)
- Experience working with secondary data sources (claims EHR registries) highly desirable
- Hands on experience with project management tools or certification will be preferred
- Strong knowledge of GCP ICH guidelines and regulatory requirements for clinical trials and bioequivalence studies
- Proficiency in Microsoft Office tools. Experience in clinical trial management software is plus
- Excellent project management skills including the ability to manage multiple projects simultaneously
- Ability to work effectively in international teams and matrix organization with multi-disciplinary teams
- Excellent communication skills spoken and written (English)
Required Experience:
Senior Manager
About Company
A global player in the world of healthcare: Fresenius Kabi! ▶ Learn more about our different expertise fields ✓ responsibilites ✓ career opportunities ✓
