- Responsible for ensuring country CRAs are trained appropriately on all aspects of the study and implementing and overseeing the Study Oversight Plan in their country which may include co-monitoring visits or coordinating Data Verification Initiatives.
- Proactively identifies country related issues and develops the Country Corrective Action and Preventive Action Plans to ensure timely and sufficient resolution of country issues that may impact the compliance or quality of study data or activities.
- Responsible Country Monthly Report and proactively notifies the Local Head of Monitoring and Site Management, Manager of MSM, Manager of Country Clinical Trial Management and Study Lead Monitor (SLM) of any potential quality, safety or commitment issues with proposed solutions to ensure country involvement in the study remains consistent with country commitments with regards to all country timelines, enrollment and country study budget.
- All of the above are relevant for internally monitored studies.
- For outsourced studies, a CLM will be assigned to ensure that relevant information regarding the Clinical Research Organization’s (CRO’s) country-related activities are cascaded through the country organization as appropriate.
- Support the CRO with regulatory and country initiation activities. The CLM or a Sr. CRA may conduct co-monitoring visits with the CRO, if required, as detailed in the Study Oversight Plan.
- Due to the increased scrutiny of regulatory authorities on the quality of clinical trial data, and increased business demands to conduct clinical trials in an efficient manner, the focus of the CLM position is strengthened to reflect greater focus on quality and oversight and achieving commitments.
- To ensure consistency, quality and efficiency across the Country CRA Study Team, a CLM is assigned for every participating country and is responsible for and oversees the CRAs and study progress at the country level from study feasibility to study archive.
- Requires significant country cross functional collaboration throughout the study conduct.
- Manage the cross-functional Country Feasibility team and process, involving the local Monitoring and Site Management and local Medical organizations. A reliable operational feasibility assessment is critical to the overall planning conduct of the global study. The CLM provides the GMSM country head (LHMSM) with advice on operational feasibility of study design, timelines, cost, patient enrollment projections, and potential sites. This process must be consistent with the Study Concept provided by the GCL and requires significant collaboration on a local cross functional level
- Lead cross-functional Site Selection Team to identify and determine interest and suitability of investigator’s for participation in the assigned study.
- Develop Core Country Study Documents to initiate the study and ensures all study sites are initiated according to planned study timelines.
- Develop the Country Enrollment and Retention Plan. Managing and tracking country site initiation, enrollment, data cleaning activities to ensure they are consistent with country commitments and study timelines. Develops contingency plan to ensure site and country commitments are met.
- Manage and tracking the Study Country Level Budget, providing monthly country budget information to Local Controlling, LHMSM and Study Manager, as well as identifying budget/estimate issues and proactively developing a plan for resolving study finance issues. The CLM manages country budget and payments in appropriate tools.
- Ensure all country CRAs are trained sufficiently for the trial. Identifies training gaps if additional training is required at country level works with the Study Lead Monitor to develop further training plans. Responsible for training all new CRAs for the study.
- Oversee Country Study Oversight Plan to ensure quality and compliance which may include co-monitoring visits and coordinating Data Verification Initiatives.
- Oversee Investigator site activities to ensure delivery of country commitments and to make certain the operational study execution is on track from site selection to site close out.
- Ensure completion of site documents necessary for ethics and regulatory approval for site initiation within agreed upon timelines. Ensuring all legal, regulatory and Sponsor requirements are met prior to drug shipment to sites as well as all site initiation processes are completed.
- Oversee country-level study activities to ensure ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs.
- Ensure applicable authorities are notified of study closure and final patient status in accordance with ICH and local regulations.
- Proactively identify potential or actual country related issues. Responsible for Country Level Corrective Action / Preventive Action Plans (CAPAs) to ensure timely and sufficient resolution of issues that may impact the quality and compliance of the data, keeping SLM and LHMSM well informed of the status of the CAPAs
- Create Country Monthly report and proactively notifying SLM, CCTM and LHMSM of any potential issues with proposed solutions to ensure country participation remains consistent with country commitments.
- 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 CLM will keep the Country Medical Director and local MSM teams informed of the status of the study. In addition, the CLM may conduct co-monitoring visits with the CRO as detailed in the Study Oversight Plan
- The CLM does not have direct reports but is responsible for overseeing the CRA activities at the country level for the assigned studies. Key work relations are with Study Lead Monitors (SLM), other CLMs, country CRAs, Study Data Manager, Study Medical Experts and country Medical Advisors.
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; 6 years of relevant healthcare experience is required.
- 4 years of monitoring & site management experience is preferred
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.