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

<h2>Your main tasks:</h2><p></p><ul><li>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:</li><li>Design and feasibility of bioequivalence studies according to target market (EU/US/PhM) requirements</li><li>Develop detailed project plans, timelines, and budgets estimates for clinical trials and bioequivalence studies</li><li>Selection, instruction and supervision of Contract Research Organizations (CROs)/study sites and collaboration with external service providers (e.g. consultants, medical experts)</li><li>Cross functional collaboration with central functions (Regulatory Affairs, <span>Pharmacovigilance/Drug</span> Safety, Drug Supply and QA etc.)</li><li>Design, development, review of clinical study protocol, CRF and study report, etc</li><li>Review of bioanalytical method validation and analysis documents</li><li>Support in compilation of regulatory documents, including clinical trial applications (CTAs) and amendments</li><li>Response to queries received from regulatory authorities and ethic committees</li><li>Ensure compliance to applicable regulatory requirements and standards</li><li><span>Monitoring/co-monitoring</span> and supervision of study sites and ensure data integrity and accuracy</li><li>Set up, review and maintenance of trial master file (e)TMF</li><li>Safeguarding the study documentation</li><li>Generation of monthly status reports according to internal reporting system</li></ul><h2></h2><h2>Your profile:</h2><p></p><ul><li>Master’s degree in life sciences, pharmacy, or a related field. Advanced degree (e.g., PhD) is preferred</li><li>At least 5 years of experience as clinical trial manager (preferably at sponsor end) with strong expertise in bioavailability (BA) and bioequivalence (BE) studies</li><li>Hands on experience with analytical tools and instruments (LC-MS/MS) will be preferred</li><li>Experience in pharmacokinetics field (e.g <span>simulation/modelling)</span> will be a plus</li><li>Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials and bioequivalence studies</li><li>Proficiency in Microsoft Office tools. Experience in clinical trial management software is plus</li><li>Excellent project management skills, including the ability to manage multiple projects simultaneously</li><li>Ability to work effectively in international teams and matrix organization with multi-disciplinary teams</li><li>Excellent communication skills, spoken and written (English)</li></ul><p></p><p></p><p></p>