Global Clinical Ops Lead - Real-World Evidence & SaMD

Median Technologies; Valbonne; On-site; EUR 110,000 - 150,000; Full time

Job summary

Median Technologies is seeking a Global Clinical Operations Manager, Post-Market Clinical Evidence, to lead global post-market studies and real-world evidence programs for our AI/ML SaMD products.

You will collaborate across Clinical Development, Medical Affairs, Regulatory, Quality, Data Science and external partners to generate high-quality evidence, ensure compliance with MDR/IVDR, FDA, GDPR, ISO 14155, and manage CROs and vendors.

Qualifications

• ,
• 7+ years of clinical operations experience in MedTech, Digital Health, Diagnostics, or Pharmaceutical industries.
• Minimum 3 years managing post-market clinical studies and/or real-world evidence programs.
• Experience with Software as a Medical Device (SaMD), digital health technologies, AI/ML-enabled medical devices, or connected health platforms strongly preferred.
• Experience managing global, multicenter studies across North America, Europe, and/or Asia-Pacific.
• Experience managing CROs and external vendors.

Responsibilities

• Lead global post-market studies, registries, observational studies, and real-world evidence initiatives.
• Develop study timelines, budgets, resource plans, risk assessments, and operational strategies.
• Oversee study conduct from initiation through final reporting and publication.
• Ensure studies are conducted in compliance with GCP, ISO 14155, MDR/IVDR, FDA regulations, and company SOPs.
• Monitor study performance against milestones and proactively implement mitigation plans.
• Select, qualify, and manage CROs, data vendors, imaging vendors, and other external partners.
• Manage vendor contracts, deliverables, performance metrics, and budgets.

Skills

Clinical operations

Real-World Evidence

Vendor management

Program management

AI/ML SaMD knowledge

Regulatory knowledge

GCP / ISO 14155 knowledge

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Advanced degree (Master's, PharmD, PhD, MPH) preferred

Tools

EDC

CTMS

eTMF

Data visualization

Job description

Median Technologies is seeking a Global Clinical Operations Manager, Post-Market Clinical Evidence, to lead global post-market studies and real-world evidence programs for our AI/ML SaMD products.

You will collaborate across Clinical Development, Medical Affairs, Regulatory, Quality, Data Science and external partners to generate high-quality evidence, ensure compliance with MDR/IVDR, FDA, GDPR, ISO 14155, and manage CROs and vendors.