Clinical Operations Vendor Category Lead (COVCL) Digital

Role Summary

Clinical Operations Vendor Category Lead, Digital. Location: Cambridge, MA; Morristown, NJ. This role blends clinical operations knowledge, digital transformation, and vendor portfolio management to drive innovation and operational excellence in digital clinical operations.

Responsibilities

• Oversee the end-to-end digital vendor landscape for clinical trials, including core R&D digital platforms and systems, emerging technology vendors, AI/ML solution providers, digital biomarker coordination, and clinical trial innovation partners.
• Collaborate with Digital R&D to align vendor strategies with broader digital transformation initiatives.
• Drive MVP evaluations and make data-driven decisions on vendor progression or termination.
• Identify opportunities for vendor consolidation and core partner strategy to support key assets.
• Exercise thoughtful risk-taking in evaluating vendor capabilities.
• Oversee vendor performance within the category and ensure operational delivery consistency.
• Set service line goals and KPI/QPI targets.
• Organize regular governance meetings for existing vendors and participate in the selection and qualification of new vendors.
• Prepare and respond to audit/inspection findings; develop immediate action plans with vendors; assist in PAI preparation and ensure inspection readiness.

Qualifications

• Bachelor's degree in Health Sciences, Clinical Research, or related discipline.
• Minimum 8 years of experience in Digital Clinical Operations and/or Clinical Operations Vendor Management.
• Experience working with internal teams and strong business acumen.
• Significant proven experience in vendor management, vendor oversight, and clinical operations knowledge with strong project management skills.
• Results-oriented with the ability to focus on outcomes and deliver business impact.
• Solid knowledge of clinical development, GCP & ICH guidelines, and regulations by major bodies (FDA and EMA) and SOPs/QDs.
• Strong leadership, decision-making, risk-taking, and problem-solving abilities; strong critical thinking; able to identify and anticipate study risks.
• Agile mindset with the ability to adapt to frequent changes, delays, or unexpected events in clinical studies; proactive change agent.
• Strong interpersonal and analytical skills; excellent written and verbal communication; strong influencing skills to build relationships with internal and external stakeholders. Proficiency in English; ability to lead international meetings, analyze data, and prepare study documents and communications.

Skills

• Strong interpersonal and analytic skills
• Excellent written and verbal communication
• Strong influencing and stakeholder-management abilities
• English proficiency for negotiations, coordination of international meetings, data analysis, and documentation