Chef de Projet Clinique

Talents Solutions; Lyon; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Talents Solutions in Lyon, France, is seeking a Senior Clinical Projects Manager to drive clinical studies across France and international markets. You will coordinate, manage, and supervise complex trials, shape regulatory strategies, and collaborate with stakeholders to advance the clinical evidence portfolio.

The role requires strategic thinking and a track record in medical devices, EU MDR, and GCP guidelines.

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

Responsabilités

• Define and align clinical study strategies with regulatory requirements
• Coordinate and manage 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 CER teams and ensure PMCF compliance
• Manage investigator contracts and ensure protocol adherence across study sites
• Lead eCRF design and data management in 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

Connaissances

Project management

Regulatory knowledge

Stakeholder management

Communication

Strategic thinking

Multitasking

Formation

Bac+3 minimum in health-related field

Outils

CTMS

e-CRF platforms

Description du poste

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