Centralized Study Associate I
2 days ago
Follow all applicable departmental Standard Operating Procedures and Work Instructions.
Complete required trainings according to required timelines.
Complete day-to-day tasks ensuring quality and productivity.
Maintain project and technical documentation in an appropriate manner.
Perform checks to ensure quality of work completed.
Ensure timely escalation as needed.
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.
Assist in the preparation of new investigator submission packages for site/regulatory submission.
Assist in Investigator Payment Processing.
Assist the study start up teams with tasks required for site start up activities. Other duties/activities as assigned by study management team, but not limited to:
- Manage clinical systems & access management.
- Manage study documents such as study level, country level and site level.
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Support study team in e-TMF management activities
- Support study team in data review and support activities.
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