Arbeitgeber: Fresenius SE & Co. KG aA

## About us Shape the successful delivery of national and international clinical studies. As Senior Manager Clinical Operations (m/f/d), you will lead complex study projects, bring internal and external partners together, and ensure that studies meet defined quality, compliance, timeline, and budget requirements. ## Your Responsibilities - Plan, organize, conduct, oversee, and evaluate national and international single-center and multicenter clinical studies in accordance with ICH-GCP, applicable regulations, and internal SOPs - Obtain and review proposals from CROs and select, guide, and oversee CROs and other external service providers - Conceptualize and prepare study protocols, case report forms, and final reports, and ensure the required entries in internal and external study databases - Continuously maintain study documentation, including the Trial Master File, and select study sites and DSMB members - Organize and conduct investigator and DSMB meetings, perform sponsor oversight activities, and support co-monitoring and oversight of study sites - Coordinate investigational product supply and document investigational product consumption, and provide information to authorities and ethics committees - Prepare for and participate in audits and inspections, and prepare and continuously implement required corrective and preventive actions (CAPAs) - Take responsibility for cost planning, budgeting, and monthly study status reporting in accordance with internal requirements - Contribute to relevant SOP updates, regulatory documents, and the presentation or publication of study results, participate in relevant congresses in coordination with the supervisor, and provide subject-matter guidance and support to colleagues ## Your Qualifications - Completed university degree in natural sciences, preferably in biology, biochemistry, pharmaceutical sciences, nutrition or a related field - At least five years of experience as a Project Manager or Clinical Trial Manager in the GCP area - Experience in guiding and supporting colleagues - Proven ability to manage several projects simultaneously within approved budgets, timelines, and quality requirements - Curiosity and openness to evolving clinical research approaches, particularly Real-World Evidence and the use of artificial intelligence - Proven ability to work independently, understand the scientific rationale of study protocols, and coordinate internal and external project contributors - High level of initiative, reliability, diligence, team orientation, flexibility, and resilience - Excellent written and verbal communication skills in English and German - Confident use of Microsoft Office and Outlook ## What we offer Bring your clinical operations expertise to an international environment and help ensure the successful delivery of high-quality clinical studies. ## Contact We look forward to receiving your application via our career site.