The posting
THE COMPANY
Global Leader in Medical Device Innovation
They are a dynamic and innovative medical device company specializing in cutting-edge solutions for spinal and orthopedic applications.
With a presence across multiple continents, they are committed to advancing clinical science and delivering exceptional patient outcomes through rigorous clinical evidence and regulatory excellence.
Their mission goes beyond compliance; they empower clinical innovation and drive the advancement of evidence-based medical solutions.
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THE OPPORTUNITY
Lead Clinical Excellence at Scale
As Senior Clinical Projects Manager, you will drive the strategic direction and execution of clinical studies across France and international markets.
This is a pivotal leadership role where you'll coordinate, manage, and supervise the deployment of complex clinical trials, shape regulatory strategies, and collaborate with key stakeholders to advance the clinical evidence portfolio.
If you are a strategic thinker passionate about advancing clinical science and regulatory excellence, this is your opportunity to make a significant impact.
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KEY RESPONSIBILITIES
Define and align clinical study strategies with organizational objectives and regulatory requirements
Coordinate and manage clinical trial planning, budgeting, and resource allocation across multiple sites
Design clinical study protocols and develop comprehensive study documentation (case report forms, investigation plans)
Lead site selection, investigator recruitment, and manage ongoing site relationships
Oversee regulatory submissions and maintain compliance with EU MDR 2017/745, ISO standards, and GCP guidelines
Monitor adverse events and manage post-market surveillance programs
Coordinate with Clinical Evaluation Report (CER) teams and ensure PMCF (Post-Market Clinical Follow-up) compliance
Manage investigator contracts and ensure protocol adherence across study sites
Lead eCRF design and data management in Clinical Trial Management Systems (CTMS)
Prepare and present clinical study results to regulatory bodies and internal stakeholders
Maintain SOPs and ensure continuous improvement in clinical operations
Foster cross-functional collaboration between clinical, regulatory, quality, and commercial teams
Champion clinical excellence and drive innovation in study design and execution
Provide expert guidance on clinical strategy and regulatory pathways
Support the development of clinical study budgets and timelines
Lead quality assurance initiatives to ensure data integrity and compliance
Communicate clinical findings to internal and external stakeholders
Continuously evaluate and optimize clinical processes and methodologies
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QUALIFICATIONS
7-10 years of progressive experience in clinical project management or clinical operations (medical devices)
University degree (Bac+3 minimum) in a health-related field (biology, pharmacy, medicine, nursing, or equivalent)
Fluent in English; French language skills are an advantage
Deep knowledge of regulatory frameworks: ISO 14971, ISO 14155, GCP guidelines, MEDDEV 2.7/1 Rev.4, EU MDR 2017/745
Proficiency with Clinical Trial Management Systems (CTMS) and electronic Case Report Form (e-CRF) platforms
Strong project management, communication, and stakeholder management skills
Ability to manage multiple complex studies simultaneously in a fast-paced environment
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WHY JOIN?
Lead strategic clinical initiatives with direct impact on product development and patient care
Work with cutting-edge medical device technology in a dynamic, innovative company
International exposure with opportunities to manage studies across European and global markets
Collaborative culture that values clinical excellence and professional development
Competitive salary and comprehensive benefits package
Located in Greater Lyon, France – a vibrant region with excellent quality of life
Opportunity to mentor junior team members and shape the future of clinical operations
Career advancement in a growing organization with global reach
