Centralized Study Associate 2
4 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. Manage project and technical documentation in an appropriate manner. Provide administrative and technical support to internal departments and teams as needed. Perform checks to ensure quality of work completed. Ensure timely escalation and issue resolution as needed. Track and report metrics as determined by management according to required timelines. Assist with the implementation of revised processes and procedures. 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. Review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines Other duties/activities as assigned by study management team, but not limited to:
- 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.
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