Spec Ii Pss

2 weeks ago

Pune, India Labcorp Full time

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.
- 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 sponsor communication portal
- Based on the Investigators enrolment plan, validate the initial drug supply demand and provide forecasting updates to sponsor as required
- Support presentations for customer governance calls.

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