Summary Of Responsibilities
- Management of complex projects under the direction of a Project Manager/Director as assigned.
- Ensure site monitoring responsibility for clinical studies are conducted according to Fortrea Standard Operating Procedures (SOP), ICH Guidelines and GCP.
- Work closely with project teams in implementation of best Trip Report review practices and applicable project plans as assigned (implementation of Initiatives either independently or with team).
- Proactively identified opportunities for process improvements and work collaboratively with project team in case further action required.
- Complete required training according to required timelines.
- Follow applicable departmental SOPs and Work Instructions.
- Proactively identified opportunities for process improvements. Lead the process improvement opportunities and manage the implementation of associated revised processes and procedures.
- Follow project issue escalation process and Fortrea Corrective action issue resolution process or clinical operations issues.
- Ensure follow-up on issues and risks and protocol deviations and to be a liaison between CRA, CTL and PM for timely resolution of issues.
- Proactively identify risks and report them to the study team.
- Responsible for timely and appropriate communication to the clinical operations team.
- Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety.
- Review progress of project and initiate appropriate actions to achieve target objectives assigned.
- CCTL-II is also the main point of contact for communication with the Global CTLs/PMS.
- Mentoring and training of new CCTL on Trip Report review processes as per ICH-GCP and SOPs and local Work Instructions.
- Performing quality check of work of current CCTL as a part of mentoring.
- Review and support development of training material and plans to support the tr
📌 Centralised Clinical Team Lead (Bengaluru)
🏢 Fortrea
📍 Bengaluru
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