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Centralized Study Associate Ii

3 weeks ago

Bengaluru, India Labcorp Full time

Centralized Study Associate II
- To complete Other duties/activities as assigned by study management team, but not limited to: Ø Manage clinical systems & access management
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Support study team in e-TMF management activities
- Support study team in data review and support activities.
- Support in generating the study specific reports
- Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks.
- Assist the Lead for any study specific data review related tasks.
- To follow all applicable departmental Standard Operating Procedures and Work Instructions.
- To complete required trainings according to required timelines.
- To complete day-to-day tasks ensuring quality and productivity.
- To manage project and technical documentation in an appropriate manner.
- To provide administrative and technical support to internal departments and teams as needed.
- To perform checks to ensure quality of work completed.
- To ensure timely escalation and issue resolution as needed.
- To track and report metrics as determined by management according to required timelines.
- To assist with the implementation of revised processes and procedures.
- To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.
- To assist in the preparation of new investigator submission packages for site/regulatory submission.
- To assist in Investigator Payment Processing
- To assist the study, startup teams with tasks required for site start up activities.
- To manage and support assigned studies for upload as per set objectives
- To follow up with study team on uploading queries

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