Senior Manager Clinical Operations

vor 12 Stunden

Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Kabi Vollzeit

Your Responsibilities

  • Planning, organization, execution, oversight and evaluation of national and international clinical trials (Phase I-IV, 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 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 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

  • 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 phase-IV studies
  • 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)

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