FSP - Clinical Team Lead - Home-Based in the USA - Oncology
Clinical Team Lead - Home-Based in the US (Country Lead Monitor)
This position requires experience as a CRA and as a Lead Monitor in Pharma and/or CRO.
Why settle for one thing when you can have everything ?
Covance gives you the best two-for-one opportunity for career growth. Who doesn't want twice the perks ? W orking at Covance-one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!
As a Covance employee dedicated to an FSP project , you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance , Covance has an FSP opportunity to match your area of expertise.
You will enjoy the best of both worlds-all the benefits that come along with Covance's Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.
Covance's FSP model is flexible and scalable. Our teams are collaborative and proactive - a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.
Covance's reach is global - extending to 60+ countries making us one of the largest FSP CROs. No matter where you are locat ed on the globe, we have an FSP opportunity for you.
Clinical Team Lead
The Clinical Team Lead (CTL) is responsible and accountable for the execution of the clinical operations component of the project, at the global or regional level, as assigned. The CTL is responsible for working cross functionally, within a matrix environment, to ensure successful execution of the trial including oversight of the clinical operations from a quality, timeline, budget and scope perspective.
Essential Job Duties:
- 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. The CTL provides the GMSM country head (LHMSM or CCRM) 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. The CTL manages country budget and payments in appropriate tools.
- 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, keeping SLM and LHMSM well informed of the status of the CAPAs
- Creating Country Monthly report and proactively notifying SLM and LHMSM of any potential issues with proposed solutions to ensure country participation remains consistent with country commitments.
- For outsourced studies: the CTL is the primary contact with the country CRO team and will support the CRO with regulatory and ethics submissions. The CTL will keep the Country Medical Director and local MSM teams informed of the status of the study. In addition, the CTL may conduct co-monitoring visits with the CRO as detailed in the Study Oversight Plan
- The CTL may be assigned monitoring and site management responsibilities when required due to study workload.
- Must have a Bachelor's Degree (or equivalent) with 6 - 7 years of relevant healthcare experience including 4 years of monitoring & site management experience
- COVID-19 vaccination required
- 2-4 years' experience as a CTL, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
•Minimum 4+ years CRA experience, on-site or in-house.
- In lieu of the above minimum requirement, candidates with 6 or more years of relevant clinical research experience in pharmaceutical, CRO or health care setting will be considered.
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