Clinical Team Lead

hace 3 días

Buenos Aires, Buenos Aires C.F., Argentina Toyotabutuan A tiempo completo

Must have a Bachelor's Degree (or equivalent) with 6 - 7 years of relevant healthcare experience including 4 years of monitoring & site management experience.
- 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 CLM 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 CLM 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 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 may be assigned monitoring and site management responsibilities when required due to study workload.
Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.
We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.

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