Clinical Operations Lead

Clinical Operations Lead (COL)

Responsible for clinical operations for a project at a regional/global level, providing oversight of deliverables, monitoring activities, and clinical research associate (CRA) and investigator site performance.

Responsibilities

• Project oversight of regional CRAs and assigned investigator sites to ensure compliance with:
  • Study protocol and monitoring plan
  • GCP and ICH guidelines
  • Local regulations and study timelines
• Serve as the primary liaison between CRAs and the clinical project team.
• Conduct monitoring support/co-monitoring visits (per project requirements) to help ensure site/CRA performance and compliance.
• Lead assessment visits of CRAs and ensure quality review of visit reports.
• Develop and maintain study tools for site and CRA use; review and track protocol deviations.
• Support enrollment and recruitment strategies and oversee implementation.
• Prepare or contribute to monitoring plan and other structural study documentation.
• Oversee monitoring visit scheduling and track site/monitoring performance metrics.
• Drive issue escalation and corrective actions.
• Oversee regional startup and feasibility activities.
• Assist with vendor management activities as required.
• Proactively manage site/country performance (recruitment, data/doc collection, TMF review, etc.) and update the clinical project team.
• Contribute to financial project management as applicable (e.g., revenue recognition input, site payments, site pass-through expense review).
• May temporarily or permanently manage/oversee investigator sites including CRA-related responsibilities.

Project liaison & training

• Run regular global and country CRA calls.
• Attend meetings with the Study Sponsor to provide status updates.
• Provide operational support and guidance to the monitoring team.
• Provide project training/mentoring to regional CRAs on study procedures, clinical plans, guidelines, and timelines.
• Ensure study-specific training is completed and documented.
• Act as first point of contact for study-specific CRA questions/issues; escalate to PM/other functions as needed.
• Support line managers with CRA utilization and performance status, including site-to-CRA assignment liaison.

Study documents and plans

• Develop training materials and study tools (including monitoring plans).
• Develop and implement enrollment and recruitment strategies with the clinical project team.
• Prepare and present materials at sponsor kickoff/investigator meetings/sponsor calls as needed.
• Prepare presentations for site qualification and site initiation visits.

Qualifications

• College diploma/degree AND 7–9 years related experience with continuous training and knowledge/skills upgrading, OR
• Undergraduate degree (Bachelor’s/Honors Bachelor’s) AND 4–6 years experience with substantial ongoing job-related training.
• Health sciences background (the text begins but is truncated).