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

Job title:

Fresenius Kabi

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)