Country Lead Monitor (CLM) is accountable and responsible for:
1.Managing the cross-functional Country Feasibility team and process, involving the local Monitoring and Site Management and local Medical organizations.
2.Leading cross-functional Site Selection Team to identify and determine interest and suitability of investigator’s for participation in the assigned study.
3.Developing Core Country Study Documents to initiate the study and ensures all study sites are initiated according to planned study timelines.
4.Developing the Country Enrollment and Retention Plan.
5. Manage country study budget
6.Ensuring all country CRAs are trained sufficiently for the trial.
7.Overseeing Country Study Oversight Plan to ensure quality and compliance which may include co-monitoring visits and coordinating Data Verification Initiatives.
8.Reporting Country Monthly report to SLM and Country Head for responsible trials.
9.For outsourced studies: the CLM is the primary contact with the country CRO team and will support the CRO with regulatory and ethics submissions.
The incumbent must have a Bachelor’s Degree (or equivalent) with 6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience.
At least 3 years oncology experience is preferred.