Gestionnaire mondial des opérations cliniques, Preuves cliniques post-commercialisation H/F

Responsibilities

We are representing a confidential medical technology organization seeking a Global Clinical Operations Manager for Post-Market Clinical Evidence. In this role, you will be responsible for planning, executing, and overseeing global post-market clinical studies and real-world evidence programs supporting AI/ML-based software as medical device products.

Your core responsibilities include:

• Lead operational planning and execution of global post-market clinical studies, registries, observational studies, health economics research, and real-world evidence initiatives
• Develop study timelines, budgets, resource plans, risk assessments, and operational strategies
• Oversee study conduct from initiation through final publication, ensuring compliance with GCP, ISO 14155, MDR/IVDR, FDA regulations, and company SOPs
• Select, qualify, and manage CROs, data vendors, imaging vendors, and other external partners
• Manage vendor contracts, deliverables, performance metrics, and budgets
• Support development and execution of real-world evidence strategies leveraging routine clinical data, registries, health economics studies, and health databases
• Collaborate with data science and AI/ML teams to ensure appropriate methodologies for performance monitoring and evidence generation
• Ensure operational compliance with ISO 14155, MDR/IVDR, FDA medical device regulations, GDPR, and local country requirements
• Support clinical evaluation reports, post-market clinical follow-up, and post-market surveillance activities
• Participate in regulatory audits and inspections
• Collaborate with clinical development, medical affairs, regulatory affairs, quality, data science, product management, and external clinical partners
• Develop and maintain study dashboards, KPIs, and operational metrics
• Provide regular updates to senior management and governance committees

What We're Looking For

Education:

• Bachelor's degree in life sciences, nursing, biomedical engineering, public health, or related discipline required
• Master's, PharmD, PhD, or MPH preferred

Experience:

• 7+ years of experience in clinical operations within medtech, digital health, diagnostics, or pharmaceutical sectors
• Minimum 3 years managing post-market clinical studies and/or real-world evidence programs
• Experience with software as medical device (SaMD), digital health technologies, AI/ML-enabled medical devices, or connected health platforms strongly preferred
• Experience managing multi-center global studies across North America, Europe, and/or Asia-Pacific
• Proven track record in managing CROs and external vendors

Technical Knowledge:

• Strong knowledge of ISO 14155, EU MDR/IVDR, FDA medical device regulations
• Understanding of post-market clinical follow-up (PMCF) and clinical evaluation processes
• Real-world evidence methodologies
• Understanding of AI/ML lifecycle management and evidence requirements for adaptive algorithms highly desirable
• Familiarity with EDC, CTMS, eTMF, and data visualization tools

Skills:

• Strong project and program management capabilities
• Excellent stakeholder and vendor management
• Strategic thinking with hands-on operational execution
• Ability to manage multiple studies and priorities simultaneously
• Strong analytical and problem-solving abilities
• Excellent written and verbal communication skills in French and English
• Collaborative leadership in a matrix environment
• High attention to quality, compliance, and regulatory expectations
• Willingness to travel internationally approximately 20-30% for investigator meetings, site visits, scientific congresses, and internal team meetings

This position is based in Valbonne, Provence-Alpes-Côte d'Azur, France.

How We Work with You

Get A Job.ai serves as the exclusive recruiting partner for this confidential client. When you apply through our platform at getajob.ai, one of our experienced recruiters will review your qualifications and conduct an initial screening. If there's a strong match, we will submit your profile to our client for consideration. Please do not attempt to contact the client directly, as all applications must be processed through Get A Job.ai to be considered.

Pay

Compensation details will be discussed during the screening process with our recruiting team.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive recruiting practices and welcomes candidates from all backgrounds. We evaluate all applicants based on qualifications and merit.