Centralized Trip Report Reviewer-i

1 week ago

Bengaluru, India Labcorp Full time

Management of projects under direction of a Project Manager / Director as assigned.
- Ensure site monitoring responsibility for clinical studies are conducted according to Standard Operating Procedures, ICH Guidelines and GCP. Work Closely with project teams in implementation of best TRR practices & applicable project plans as assigned (Implementation of Initiatives either independently or with team)
- Proactively identify opportunities for process improvements and work collaboratively with project team incase further action required
- Complete required trainings according to required timelines.
- Follow applicable departmental Standard Operating Procedures and Work Instructions
- Follow project issue escalation process and Corrective Action Issue Resolution (CAIR) process for 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
- Responsible for the 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. Support in review of Standard Operating Procedures or Work Instructions to align with process or tool modifications
- Other duties as assigned by management: Ex: Document Review, ETMF reconciliation, other CTL tasks etc.

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