Covance

Senior Clinical Team Lead

Job Location(s) IN-Mumbai
Job Number
2020-52532
Job Category
Clinical Operations Management
Position Type
Full-Time
Telecommute
No

Job Overview

The Senior 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 Senior 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.
 
- Responsible and accountable for the management of the Clinical Operations team with particular emphasis on teamwork, quality, timelines, budget, metrics and compliance with the project plans and SOPs
- Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: pre-study visits, site initiation visits, routine monitoring visit, motivational visits, close-out visits, audit support visits
- Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines
- Ensure that all study related, clinical related documents are tracked, filed and reviewed (QC check) and complete according to the SOPs, regulatory requirements and protocol
- Responsible and accountable for understanding and managing the clinical operations budget for the project, and ensure that the activities are within budget and scope of work, and to discuss with the project team to support financial progress, and team utilization
- Communicate effectively with all members of the project team and client as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with Quality and the project team on Corrective and Preventative Actions
- As required by the project roles participate and oversee the site selection process; depending on the scope and roles within the project team, this may be performed in collaboration with other team members
- As required by the project roles participate and oversee the regulatory/ethics committee submissions, tracking and documentation
- Support new business with active participation in bid defense preparation and meetings, as required
- Perform other duties as required by the department or project team

Education/Qualifications

Must have a Bachelor’s Degree (or equivalent).

Experience

8 – 10 years of relevant healthcare experience including minimum 5 -6  years of monitoring & site management experience, 0-4 years’ experience as a CPL.

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