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Job Description
- Manage the set-up, planning, and maintenance of clinical studies in the client Portal
- Maintain a strong understanding of client conventions or client specific database conventions, as appropriate
- Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided
- Support/train/mentor less experienced safety staff in all aspects
- Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives
- Participate in project team and internal meetings, as appropriate
- Prepare and support coordination of ISR study files for archiving at completion of projects
- Ensuring that the IST investigator is providing study updates as applicable to the customer viz. regulatory updates, enrolment data, confirming that safety information is being transferred to customer as required, notification of any amendments to either the protocol or informed consent.
- Regular follow up with the customer POCs for updates on the protocol/study design. Cascading and tracking the same with the investigator.
- Monitoring eTMF compliance based on the eTMF filing plan and providing guidance to the Investigator site staff via raised queries in the BMS FastTrack communication portal
- Based on the Investigators enrolment plan, validate the initial drug supply demand and provide forecasting updates to BMS as required
- Support presentations for customer governance calls.
- Any other duties as assigned by management.