(Senior) Manager Clinical Operations (m/f/d)

Fresenius Kabi; Deutschland; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

A leading healthcare company in Germany is seeking a Clinical Trial Manager to oversee the planning and execution of national and international clinical trials. The role requires a Master's degree in life sciences or pharmacy, at least 5 years of experience in clinical trial management, and strong expertise in bioequivalence studies. Excellent project management skills and experience working in international teams are essential. This position offers a dynamic work environment with significant responsibilities.

Qualifikationen

• At least 5 years of experience as clinical trial manager.
• Strong expertise in bioavailability and bioequivalence studies.
• Knowledge of GCP, ICH guidelines, and regulatory requirements.

Aufgaben

• Plan and oversee national and international clinical trials.
• Design feasibility studies according to market requirements.
• Collaborate with CROs and external service providers.

Kenntnisse

Clinical trial management

Project management

Regulatory compliance

Bioequivalence studies

Analytical tools (LC-MS/MS)

Excellent communication skills

Ausbildung

Master's degree in life sciences or pharmacy

PhD preferred

Tools

Microsoft Office

Clinical trial management software

Jobbeschreibung

Your main tasks:

• Planning, organization, execution, oversight and evaluation of national and international clinical trials (Phase I-IV, focus on bioequivalence studies) according to ICH-GCP, other applicable legislations and internal standard operating procedures (SOPs). This includes the following tasks:
• Design and feasibility of bioequivalence studies according to target market (EU/US/PhM) requirements
• 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 bioanalytical 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:

• Master's 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) with strong expertise in bioavailability (BA) and bioequivalence (BE) studies
• Hands on experience with analytical tools and instruments (LC-MS/MS) will be preferred
• Experience in pharmacokinetics field (e.g simulation/modelling) will be a plus
• 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)