Sr. Clinical Operations Lead (Clinical Trial Manager)

Project Oversight

Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.

Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.

Project Liaison

Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls.

Attend meetings with Study Sponsor to provide status updates on country and site progress.

Provide operational support and guidance to the monitoring team throughout project.

Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study.

Ensure study specific training requirements are completed and documented.

First point of contact for regional CRAs for study-specific questions and issues.

Escalates to PM and other functions as appropriate.

Support line managers by providing status updates on utilization and performance of CRAs.

Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.

Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.

Study Documents and Plans

Develop training materials and study tools for sites and CRAs, including monitoring plans.

Develop and implement enrolment and recruitment strategies together with clinical project team.

Prepare presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.