Global Clinical Operations Manager, Post-Market Clinical Evidence F/M

The Global Clinical Operations Manager, Post-Market Clinical Evidence F/M is responsible for the planning, execution, and oversight of global post-market clinical studies and real-world evidence (RWE) programs supporting AI/ML-based Software as a Medical Device (SaMD) products.

This role ensures the generation of high-quality clinical evidence to support product performance, safety, effectiveness, reimbursement, market access, and regulatory compliance throughout the product lifecycle. The successful candidate will collaborate closely with Clinical Development, Medical Affairs, Regulatory Affairs, Quality, Data Science, Product Management, and external clinical partners to execute multinational post-market studies in accordance with applicable regulations and industry standards.

The position plays a critical role in supporting continuous clinical evaluation, post-market surveillance activities, and evidence generation strategies required for global regulatory frameworks, including MDR/IVDR, FDA requirements, and emerging AI/ML-specific guidance.

Key Responsibilities

Post-Market Clinical Study Management

• Lead the operational planning and execution of global post-market clinical studies, registries, observational studies, medico- economics 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.

Vendor Management

• Select, qualify, and manage CROs, data vendors, imaging vendors, and other external partners.

• Manage vendor contracts, deliverables, performance metrics, and budgets.

Real-World Evidence & Data Generation

• Support development and execution of RWE strategies leveraging routine clinical data, registries, medico economics studies, and healthcare databases.

• Collaborate with Data Science and AI/ML teams to ensure appropriate methodologies for performance monitoring and evidence generation.

• Contribute to evidence generation supporting algorithm validation, clinical utility, and health economic outcomes.

Regulatory & Quality Compliance

• Ensure operational compliance with:

  • ISO 14155

  • MDR / IVDR

  • FDA regulations

  • GDPR and applicable privacy laws

  • Local country requirements

• Support Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF), and Post-Market Surveillance (PMS) activities.

• Participate in audits and regulatory inspections.

• Maintain accurate trial master files and study documentation.

Cross-Functional Collaboration

• Partner with Clinical Development and Medical Affairs to implement global evidence-generation strategies.

• Partner with the clinical project coordinator to ensure budget and timelines are respected

• Collaborate with Regulatory Affairs to support submissions, renewals, and lifecycle management activities.

• Work closely with Biostatistics, Data Management, Product, and AI/ML teams to ensure studies meet scientific and regulatory requirements.

• Contribute operational expertise to clinical and product development planning.

Reporting & Analytics

• Develop and maintain study dashboards, KPIs, and operational metrics.

• Provide regular status updates to senior leadership and governance committees.

• Analyze operational performance trends and implement continuous improvement initiatives.

Education

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, Public Health, or related discipline required.

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

Experience

• 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.

Knowledge & Technical Expertise

• Strong knowledge of:

  • ISO 14155

  • EU MDR / IVDR

  • FDA medical device regulations

  • Post-Market Clinical Follow-up (PMCF)

  • Clinical Evaluation processes

  • Real-World Evidence methodologies

• Understanding of AI/ML lifecycle management and evidence requirements for adaptive algorithms is highly desirable.

• Familiarity with EDC, CTMS, eTMF, and data visualization tools.

Competencies

• Strong project and program management skills

• 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 capabilities

• Excellent written and verbal communication skills

• Collaborative leadership in a matrix environment

• High attention to quality, compliance, and regulatory expectations

Travel

Approximately 20-30% international travel, including investigator meetings, site visits, scientific congresses, and internal team meetings

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