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Clinical Project Manager
il y a 4 semaines
Who we are 1MED is a mission-driven MedTech CRO (Contract Research Organization) dedicated to supporting the development and clinical validation of innovative medical technologies.We specialize in guiding medical device and Pharma companies through the regulatory, clinical, and operational challenges of bringing safe and effective products to market.With offices in France, Switzerland, and Italy, our team combines deep technical expertise with a collaborative, patient-centered approach. Across Europe, we pride ourselves on a culture of integrity, excellence, and innovation, ensuring that every project we manage not only meets regulatory standards but also contributes to improving healthcare outcomes.Role SummaryWe are currently seeking an experienced Project Manager with a strong MedTech background to lead and oversee clinical investigations for medical devices and IVDs.You will join our growing French operations based in Caen, working in a hybrid model while collaborating closely with colleagues across Europe.This role ensures that projects are delivered on time, within scope, in compliance with ISO 14155, MDR/IVDR, and FDA requirements, and aligned with 1MED’s culture and processes.Key ResponsibilitiesLead end-to-end project planning, execution, monitoring, and closure for clinical investigations.Act as the primary liaison for sponsors, investigators, and internal teams.Manage timelines, budgets, risk assessments, and communication plans.Ensure compliance with ISO 14155, MDR/IVDR, FDA requirements, and GCP.Coordinate cross-functional teams: clinical operations, data management, Biostatistics, regulatory, and quality.Track project KPIs and proactively resolve issues or delays.Conduct study kickoffs, project meetings, and milestone reviews.Contribute to proposals, client presentations, and bid defenses when needed.Support continuous improvement of PM methodologies and tools.Qualifications Required:Bachelor’s or Master’s in Life Sciences, Biomedical Engineering, or related field.3–5+ years of project management experience in MedTech or clinical research.Strong understanding of ISO 14155, MDR/IVDR, and/or FDA pathways.Proven experience managing multiple complex projects.Excellent communication and stakeholder management skills.Fluency in English; French proficiency required.Preferred:Experience working in a CRO environment.PMP, PRINCE2, or equivalent certification.Experience with digital health, SaMD, or IVD clinical studies.What We OfferA mission-driven culture centered on caring, unity, and regulatory-aligned delivery.The opportunity to influence clinical development strategies for innovative MedTech solutions.Exposure to a wide range of medical technologies—from implants to diagnostics to digital health.A collaborative European team committed to operational excellence.Competitive salary, benefits, and opportunities for advancement.We are looking forward to receiving your CV
