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Clinical research project manager, thv, medical affairs (temporary role)

Bremen
Edwards Lifesciences
Projektmanager
Inserat online seit: 2 August
Beschreibung

Patients are at the heart of everything we do. As part of our Medical Affairs team, youu2019ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. We are looking for a proactive and detail-oriented Clinical Research Project Manager to join our Medical Affairs team focused on Structural Heart Disease, with a specific emphasis on Transcatheter Heart Valves (THV). This role will be responsible for the end-to-end management of research studies, including investigator-initiated studies (IIS) and company-sponsored research, while also overseeing contracting processes with external partners and institutions. This is a short-term assignment for four months (September - December), with the potential for extension. How youu2019ll make an impact: Clinical Research Management Lead the planning, initiation, execution, and close-out of clinical research projects in alignment with medical strategy. Coordinate with investigators, study sites, and internal stakeholders to ensure timely and compliant study execution. Monitor study progress, timelines, and deliverables, ensuring adherence to protocols and regulatory requirements. Contracting & Budget Oversight Manage the contracting process for research collaborations, including drafting, reviewing, and tracking contracts and budgets. Liaise with Legal and Compliance to ensure alignment with internal policies and external regulations. Cross-Functional Collaboration Work closely with Medical Affairs, Clinical Operations, Regulatory, and Finance teams to ensure seamless project execution. Serve as the primary point of contact for research-related inquiries and documentation. Documentation & Compliance Ensure proper documentation of study activities, including protocols, agreements, ethics submissions, and study reports. Maintain compliance with Good Clinical Practice (GCP), company SOPs, and local regulatory requirements. This is a short-term assignment for four months (September - December), with the potential for extension. What you'll need (Required): University degree in Life Sciences (e.g. Biomedical Sciences, Biology, Pharmacy, etc.) Minimum 3 years of experience in clinical research project management, preferably in cardiovascular or structural heart disease. Proficiency in English. What else we look for (Preferred): Familiarity with contracting processes and budget management in a clinical research setting. Strong organizational and project management skills with attention to detail. Excellent communication and interpersonal skills. Experience in Medical Affairs or Clinical Operations within the MedTech or pharmaceutical industry. Understanding of THV technologies and the clinical landscape of structural heart interventions. Experience working with European research institutions and healthcare systems. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwardsu2019 groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. Itu2019s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

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