Clinical Operations Vendor Category Lead (COVCL) Digital

Role Summary

Clinical Operations Vendor Category Lead, Digital. Location: Cambridge, MA and Morristown, NJ. Responsible for end-to-end operational strategy and delivery of the digital vendor landscape for clinical trials, driving innovation and operational excellence, overseeing vendor performance, governance, and collaboration with procurement and quality to support study delivery.

Responsibilities

• Oversee the end-to-end digital vendor landscape for clinical trials, including Core R&D digital platforms and systems, emerging technology vendors, AI/Machine Learning solution providers, and digital biomarker initiatives in coordination with the strategy team.
• 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 on vendor capabilities.
• Oversee vendors' performance within the category and ensure operational consistency of delivery; set service line goals and KPIs/QPIs.
• Organize regular governance meetings for existing vendors; participate in selection and qualification of new vendors.
• Support study and vendor audits/inspections; ensure audit responses and action plans with vendors; assist in inspection readiness.
• Utilize change management techniques to drive new ways of working to empower vendor success.

Qualifications

• Required: Bachelors degree in Health Sciences, Clinical Research, or related discipline.
• Required: Minimum 8 years of experience in Digital Clinical Operations and/or Clinical Operations Vendor Management.
• Required: Experience working with an internal team and strong business acumen.
• Required: Significant experience in vendor management, vendor oversight, and managing clinical studies with strong project management skills.
• Required: Results-oriented with ability to focus on outcomes, think differently, and drive business impact.
• Required: Solid knowledge of clinical development, GCP & ICH guidelines, and regulatory requirements (FDA, EMA) and SOPs/QDs.
• Required: Strong leadership, decision-making, risk management, problem-solving, critical thinking, and ability to interface with senior stakeholders.
• Required: Agile mindset with adaptability to frequent changes, delays, or unexpected events in clinical studies; ability to drive change.
• Required: Strong interpersonal and analytic skills; excellent written and verbal communication; ability to influence internal and external stakeholders; fluency in English (negotiation, international meetings, data analytics, documentation).
• Preferred: Experience collaborating with cross-functional teams and vendor partners to achieve study goals.

Education

• Bachelors degree in Health Sciences, Clinical Research, or related discipline.