Clinical Study Manager

Clinical Study Manager Full-time · On -site · Minneapolis, Minnesota, U.S. At TRiCares, we are dedicated to providing innovative, minimally invasive treatment solutions for patients suffering from failing tricuspid valves. As a growing MedTech company based in Munich, we are looking for a proactive and skilled Clinical Stu dy Manager to join our dynamic team and support us in our mission to improve patient care. This is a unique opportunity to join a growing medical device company, where you will be part of a passionate and international team working towards transforming the landscape of cardiovascular treatment through innovative technology. The Clinical Study Manager will lead the day -to-day execution 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 timelines, data quality, and ensuring the study is inspection -ready from start -up through closeout. Key Responsibilities: • Manage all operational aspects of the study from site selection through database lock, PMA submission and closeout. • Lead study team meetings and coordinate cross functional activities across clinical, data management, safety, biostatistics, regulatory, and quality teams. • Oversee study start -up activities, including site activation, contracts, IRB approvals, and site training. • Monitor enrolment and site performance, identify risks early, and implement plans to keep recruitment on track. • Manage CROs and vendors, ensuring deliverables, timelines, and budgets are met. • Review monitoring reports, track study issues, and ensure corrective actions are completed. • Maintain TMF quality and inspection readiness throughout the study. • Track study budgets, site payments, and vendor invoices, escalating potential budget concerns as needed. • Coordinate protocol amendments, including site communications, re -consenting activities, and regulatory submissions. • Support database lock, study closeout, investigational product reconciliation, and final site payments. Qualifications and Experience : • Bachelor's degree in Life Sciences, Nursing, or a related field. • 7+ years of clinical research experience, including management of medical device studies. • Experience managing IDE and/or pivotal clinical trials. • Strong understanding of FDA regulations, GCP , and ISO 14155. • Experience working with CROs, investigators, and cross -functional teams. • Strong project management, communication, and organizational skills. Preferred: • Cardiovascular, structural heart, or Class III medical device experience. • Experience supporting PMA submissions. • Startup or fast -growth medical device company experience. • ACRP or SOCRA certification. What We Offer: • A dynamic and forward -thinking work environment, shaping the future of transcatheter heart valve therapy • The opportunity to work in a truly international team, with talented and driven colleagues from around the globe • A strong company culture rooted in collaboration, innovation, and purpose • Excellent opportunities for personal and professional development in a fast -growing MedTech company • A competitive compensation and benefits package tailored to your experience and contribution • Regular team events and offsites to connect, celebrate successes, and foster team spirit • An inclusive and respectful workplace where diversity is not only welcomed but valued Ready to make a difference? We look forward to receiving your application. Join us on our journey to transform patient care - one heartbeat at a time. Apply now at: hr@tricares.de.