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

Job title:

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

Company:

Fresenius Kabi

Job description

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)

Expected salary

Location

Bad Homburg vor der Höhe, Hessen

Job date

Wed, 02 Jul 2025 02:13:24 GMT

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