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
Impart process trainings within the team for sign off and refresher trainings as applicable
Supporting the leads on preparation of the dashboards as required on a regular interval
Ensuring that the agreed upon contractual milestones are being met and raising to customer for any threats to the milestones or if any milestones are missed
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
Review Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guideline.
Review protocol and protocol amendments to assure compliance with sponsor requirements, reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines
Support presentations for customer governance calls
