Employment

Edwards Lifesciences is hiring a Clinical Research Project Manager, THV, Medical Affairs (Temporary role)

About the Role

Edwards Lifesciences seeks a proactive, detail-oriented Clinical Research Project Manager for a temporary assignment spanning four months (September - December) with potential for extension. You will join the Medical Affairs team, focusing on Structural Heart Disease with a specific emphasis on Transcatheter Heart Valves (THV). The role is responsible for the end-to-end management of investigator-initiated and company-sponsored research studies, including oversight of contracting processes.

What You'll Do

  • 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.
  • 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.
  • 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.
  • 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.

What We're Looking For

  • A university degree in Life Sciences (e.g., Biomedical Sciences, Biology, Pharmacy).
  • Minimum 3 years of experience in clinical research project management, preferably in cardiovascular or structural heart disease.
  • Proficiency in English.

Nice to Have

  • 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.

Team & Environment

You will be part of the Medical Affairs team focused on Structural Heart Disease and Transcatheter Heart Valves (THV). At Edwards Lifesciences, patients are at the heart of everything we do. We foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care.

Required Skills
Clinical ResearchProject ManagementMedical AffairsRegulatory SubmissionsClinical Trial ManagementData AnalysisStakeholder ManagementCardiologyTranscatheter Heart Valve (THV)
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Edwards Lifesciences

A global leader in patient-focused medical innovations.

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Posted 8 months ago