Sr. Clinical Operations Lead (Clinical Trial Manager)

About the role

Responsible for the clinical operations of a project within a defined regional or global level. Provides oversight of project deliverables, assigned Clinical Research Associates (CRAs), and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, and local regulations. Acts as the primary liaison between CRAs and the clinical project team.

Responsibilities

• Overall oversight of regional CRAs to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations, and study timelines.
• Conduct monitoring support visits (Co-monitoring) to aid sites and CRAs in satisfactory performance and compliance.
• Support the clinical project team by overseeing study deliverables related to other departments (e.g., Data Management, TMF Operations).
• Oversee regional startup and feasibility activities.
• Assist in vendor management activities as required.
• Review visit reports for quality, compliance, and appropriate site management.
• Ensure compliance with high-quality and timely project deliverables according to project requirements and the monitoring plan.
• Proactively manage site and country performance (recruitment, data collection, document collection, TMF review) and report progress to the clinical project team.
• Contribute to financial project management processes, including input on revenue recognition, site payments, and site pass-through expense review.
• Manage or oversee investigator sites, including CRA responsibilities, on a temporary or permanent basis if required.
• Conduct regular global and regional CRA calls with the monitoring and site management team.
• Attend meetings with Study Sponsor to provide status updates on country and site progress.
• Provide operational support and guidance to the monitoring team throughout the project.
• Train and mentor regional CRAs on study procedures, clinical plans, guidelines, and timelines; ensure study-specific training requirements are completed and documented.
• Serve as the first point of contact for regional CRAs for study-specific questions and issues; escalate to the Project Manager and other functions as appropriate.
• Support line managers by providing status updates on utilization and performance of CRAs.
• Liaise with line managers for assigning sites to CRAs following resource allocation to the project.
• Conduct CRA Assessment visits to evaluate performance against monitoring responsibilities.
• Develop training materials and study tools for sites and CRAs, including monitoring plans.
• Develop and implement enrollment and recruitment strategies with the clinical project team.
• Develop presentation materials for Sponsor Kickoff meetings, Investigator meetings, and Sponsor Calls; prepare presentations for Site Qualification Visits and Site Initiation Visits.

Qualifications

• College diploma/degree and 7–9 years of related experience with continuous training and skills upgrading, or undergraduate university degree (Bachelor’s or Honors Bachelor’s) and 4–6 years of experience with substantial ongoing job-related training.
• Health Sciences, Life Sciences, or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
• Minimum of 3 years of CRA experience.
• Strong experience with EDC systems and proficiency with MS Office.
• Strong written and verbal communication skills, highly effective interpersonal and organizational skills.
• Proactive, detail-oriented, task-driven, and highly organized.
• Demonstrated knowledge of GCPs and local regulations as they relate to clinical monitoring, IRB/EC, and Investigator responsibilities.
• Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
• Ability to handle multiple tasks and meet deadlines in a dynamic environment.

Schedule

Home-based.