Clinical Research Project Manager, THV, Medical Affairs (Temporary role)

Edwards Lifesciences; Gaja-et-Villedieu; Sur place; EUR 40 000 - 60 000; Temps partiel

Résumé du poste

A leading medical technology company in Occitanie is seeking a Clinical Research Project Manager to oversee the end-to-end management of research studies focused on Structural Heart Disease. This short-term role includes coordinating with investigators, managing budgets, and ensuring compliance with regulatory requirements. Candidates should possess a Life Sciences degree and at least 3 years of related experience, preferably in cardiovascular research.

Qualifications

• Minimum 3 years of experience in clinical research project management, preferably in cardiovascular or structural heart disease.
• Familiarity with contracting processes and budget management in a clinical research setting.
• Strong organizational and project management skills with attention to detail.

Responsabilités

• Lead the planning, initiation, execution, and close-out of clinical research projects.
• Manage the contracting process for research collaborations.
• Ensure proper documentation of study activities and compliance with regulations.

Connaissances

Clinical Research Management

Contracting & Budget Oversight

Cross-Functional Collaboration

Documentation & Compliance

Proficiency in English

Formation

University degree in Life Sciences

Description du poste

Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll 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 you’ll 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. Edwards’ 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. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.