Director, Clinical Technology Oversight Lead

Responsibilities

• Design and implement a global Clinical Technology Vendor Governance Framework aligned with ICH GCP E6 R3 and regulatory standards.
• Oversee day-to-day vendor performance for technologies like EDC, eCOA, RTSM, eTMF, RBM, digital health solutions, and AI-driven systems.
• Define KPIs, SLAs, and metrics tied to study timelines, data quality, system performance, and delivery reliability.
• Establish robust AI governance frameworks ensuring transparency in intended use, decision boundaries, risk classification, validation processes, and lifecycle management.
• Proactively manage risks through monitoring systems while maintaining inspection readiness for regulatory audits.
• Serve as the central escalation point for issue resolution across internal teams and external vendors.
• Drive strategic oversight of technology vendors to optimize scalability and cost‑efficiency while fostering trust‑based partnerships.

• Relevant degree in Vendor Management, Clinical Operations, Business Administration, Program Management or related discipline
• 12 years of clinical technology management experience with expertise in clinical trial technologies (EDC/eCOA/RTSM/eTMF/RBM/digital health) and AI/ML applications in trials
• Strong understanding of system architectures (APIs/data flows), cloud‑based platforms (SaaS models), AI/ML fundamentals (bias/drift/validation), vendor oversight (SLAs/performance), and computerized system validation expectations
• Proven ability to translate complexity into clear governance structures while managing interdependencies across systems/processes
• Exceptional interpersonal skills with experience influencing stakeholders in matrix environments
• Fluency in English is required;
  German is advantageous.
• Resilience in overcoming challenges coupled with agility to adapt to dynamic circumstances.

Demonstrates expertise in Clinical Technology Vendor Governance, with a strong focus on ICH GCP E6 R3 compliance, AI governance frameworks, and vendor performance management. Proven ability to establish KPIs and SLAs while ensuring inspection readiness and effective risk management.