Clinical Study Manager

Clinical Study Manager Full-me · On-site · Minneapolis, Minnesota, U.S. At TRiCares, we are dedicated to providing innovave, minimally invasive treatment solu ons for paents suering from failing tricuspid valves. As a growing MedTech company based in Munich, we are looking for a proac ve and skilled Working Student - Clinical Travel & Event Support to join our dynamic team in Munich and support us in our mission to improve pa ent care. This is a unique opportunity to join a growing medical device company, where you will be part of a passionate and interna onal team working towards transforming the landscape of cardiovascular treatment through innova ve technology. The Clinical Study Manager will lead the day-to- day execu on of a global pivotal IDE clinical study, working closely with sites, CROs, vendors, and internal teams to keep the trial on track. This role is responsible for enrolment , study melines, data quality, and ensuring the study is inspecon-ready from start-up through closeout. Key Responsibili es: Manage all opera onal aspects of the study from site selec on through database lock, PMA submission and closeout. Lead study team mee ngs and coordinate cross func onal acvies across clinical, data management, safety, biosta scs, regulatory, and quality teams. Oversee study start- up acvies, including site ac vaon, contracts, IRB approvals, and site training. Monitor enrolment and site performance, iden fy risks early, and implement plans to keep recruitment on track. Manage CROs and vendors, ensuring deliverables, melines, and budgets are met. Review monitoring reports, track study issues, and ensure correc ve acons are completed. Maintain TMF quality and inspec on readiness throughout the study. Track study budgets, site payments, and vendor invoices, escala ng potenal budget concerns as needed. Coordinate protocol amendments, including site communica ons, re-consenng acvies, and regulatory submissions. Support database lock, study closeout, inves gaonal product reconcilia on, and nal site payments. Qualicaons and Experience : Bachelor's degree in Life Sciences, Nursing, or a related eld. 7+ years of clinical research experience, including management of medical device studies. Experience managing IDE and/or pivotal clinical trials. Strong understanding of FDA regula ons, GCP, and ISO 14155. Experience working with CROs, inves gators, and cross -funconal teams. Strong project management, communica on, and organiza onal skills. Preferred: Cardiovascular, structural heart, or Class III medical device experience. Experience suppor ng PMA submissions. Startup or fast-growth medical device company experience. ACRP or SOCRA cer caon. What We Oer: A dynamic and forward-thinking work environment, shaping the future of transcatheter heart valve therapy The opportunity to work in a truly interna onal team, with talented and driven colleagues from around the globe A strong company culture rooted in collabora on, innova on, and purpose Excellent opportuni es for personal and professional development in a fast -growing MedTech company A compeve compensa on and benets package tailored to your experience and contribuon Regular team events and osites to connect, celebrate successes, and foster team spirit An inclusive and respec ul workplace where diversity is not only welcomed but valued Ready to make a dierence? We look forward to receiving your applica on. Join us on our journey to transform pa ent care - one heartbeat at a me. Apply now at: hr@tricares.de.