Clinical Team Leader
This position will manage and direct the efforts of a designated group of monitors in order to ensure effective oversight,
coordination & monitoring of clinical research projects along with training and development of team. In addition, this position
will also act as the key operational interface in the management of clinical trials including participation in the monitoring of
The incumbent should have a minimum 4 - 5 years of healthcare/bio-pharmaceutical management experience out of which 3 years should
be purely be clinical trial management experience (in the capacity of CRA, investigator/sub-investigator, lead site coordinator,
Auditor etc). The candidate should have worked for 2 years in the capacity of site monitor for phase I to phase III clinical
trials either in CRO or a bio-pharmaceutical company. Prior line management experience managing a minimum team size of 4-5 persons
is a must.
Understanding of clinical research process, the drug development process and ICH GCP is a must.
The Core Responsibilities for the position would be:
- To lead and supervise CRAs in activities of clinical trials; delegate tasks commensurate with skill levels while increasing knowledge base.
- To independently manage/handle assigned clinical study (of less complexity) in the capacity of project manager.
- To perform the Site Qualification Visit across the studies to identify the appropriate site for the project(s).
- To prepare the study budget in consultation with project manager/line manager/business development team for the assigned projects.
- To prepare the project/monitoring plan for the study.
- To track and ensure that project timelines/milestones are being met. Also, to maintain and update different trackers to evaluates the progress of the study.
- To monitor progress of all trials on an ongoing basis relative to established timelines and key milestones. Ensure that delays are identified and communicated to line manager/department head/project manager in a timely manner.
- To participate in and facilitate efforts to implement appropriate interventions across functional groups in order to meet timelines.
- To ensure timely initiation of study centres, appropriate follow-up (co-monitoring, review of reports, recruitment tracking) and close-out (files archived, IP and trial material collected) of study centres on the assigned projects.
- To ensure that dossier and/or appropriate documentation for regulatory/ethics submission or other appropriate bodies (i.e. Directorate general of Foreign Trade etc) is prepared and done on time and as per required format to avoid unnecessary delays in obtaining study related approval(s).
- To provides resolution for issues impacting team members.
- To act as the key operational interface in the management of clinical trials including participation in the monitoring of clinical studies if required.
- To identify operational problems, issues, obstacles, and barriers across all projects based on input from projects managers, investigators, project team members, and sponsors; communicate patterns and trends to line manager/department head as appropriate; and participate in and support efforts to develop and implement process/system improvements.
- To contribute in the preparation and implementation of project specific training programs and training materials for internal and external staff.
- To monitor expenditure of funds related to budgetary targets for assigned trials on an ongoing basis. Ensure that variances are identified and communicated to appropriate personnel in a timely manner. Facilitate efforts to implement appropriate interventions.
- To provide inputs to the line manager regarding financial information on a timely basis to effectively monitor financial performance of trials.
- To participate in and facilitate efforts to ensure that all trial related expenses are accurately and appropriately recorded in a timely manner.