- Bangalore, India
Site Name: India - Karnataka - Bangalore
Posted Date: Jan 13 2020
Clinical Document management exposure a definite requirement
Scientific background and knowledge of clinical trials (including ICH-GCP) is an asset
Microsoft office (Excel, PowerPoint, Word, Outlook, MS Project)
Advanced Excel, MS project, eTrack, Documentum and SAP are an asset
Time management skills, ability to clearly identify priorities and manage multiple tasks
Good understanding of the principles of project planning & project management.
- Provide operational and administrative support for the study TMF management.
- Ensure high quality and up-to-date TMF management in clinical study teams. The role is embedded into several study teams.
- Own and maintain the study TMF management plan and ensures adherence by the study team members
- Supports the SDL in planning and executing TMF management related activities of the clinical trial teal in order to ensure that the TMF is in good shape ad updated on a timely manner.
- Responsible to track eTMF periodic reviews for studies and provides regulars updates to the SDL/ Head TMF Operations
- Primary point of contact for study team members for any TMF-related question
- Support document owners to ensure TMF compliance.
- In charge of the set-up of the TMF for each new study (on-boarding of study contributors, TMF plan, performing preparation of the documents in the system)
- In charge, during the maintenance of the TMF that the contributors are providing their documentation in an in-stream basis (by running KPI, by running reports, by running QC checks if needed).
- Take the appropriate relevant actions to address gaps, issues and risks
- Provide training to newcomers and refresher training to existing users.
- Act in a network across study and project assignments to make best use of location and time-zone
- Collect study wet-ink paper documents, prepares the wet-ink documents for archiving, arrange shipments of those to the clinical archive team for long term retention
- May lead inspection/audit preparation related activities with regards to study-related documentation for studies in their Region providing documentation in timely manner and assisting with CAPAs as related to TMF finding in the region.
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