Local Clinical Study Manager - South of England
- Experience Level
- Experienced (non-manager)
This is a Local / Domestic Study Manager role to work on Oncology trials. You will be permanently employed by Covance but 100% dedicated to a Pharmaceutical company who have their head offices in the South of England. Although the position is home-based there will be the need to travel into the office once a week. As such candidates must be based in the Southern section of the UK; somewhere between the Midlands and the South Coast.
The client is ideally looking for individuals with a formal CRA background and exposure to Oncology trials is strongly preferred too.
Diuties will include:
- Managing 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. Provides the country head 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.
- Leading cross-functional Site Selection Team to identify and determine interest and suitability of investigator's for participation in the assigned study.
- Developing Core Country Study Documents to initiate the study and ensures all study sites are initialed according to planned study timelines.
- Developing 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.
- Managing and tracking the Study Country Level and site 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.
- Ensuring 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.
- Overseeing Country Study Oversight Plan to ensure quality and compliance which may include co-monitoring visits and coordinating Data Verification Initiatives.
- Proactively identifying potential or actual country related issues. Responsible for Country Level Corrective Action I Preventive Action Plans (CAPAs) to ensure timely and sufficient resolution of issues that may impact the quality and compliance of the data.
- For outsourced studies, is the primary contact with the country CRO team and will support the CRO with regulatory and ethics submissions.
- Keep the Country Medical Director and local MSM teams informed of the status of the study.
To apply please contact Andy Smith on 07775 848 259 or mail your CV to firstname.lastname@example.org
Must have a Bachelor's Degree (or equivalent).
6 - 7 years of relevant healthcare experience including 4 years of monitoring & site management experience.
Ideally you will have experience of working on Oncology trials