Etmf Specialsit

Manage clinical systems & access management
- Manage study documents and support eTMF management
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Support study team in data review and support activities.
- Track and follow up with CRAs for outstanding issues
- Support in generating the study specific reports.
- Manage internal/external communication
- Assist in ensuring training compliance for study teams

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 participate in process improvement opportunities and 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, Site budget validation and related activities To assist the study start up teams with tasks required for site start up activities. To review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines.

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