Spec II PSS Full-time Job

Ensuring that the IST investigator is providing study updates in tool 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. Reviewing 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 communication portal Based on the Investigators enrolment plan, validate the initial drug supply demand and provide forecasting updates to customer as required Support presentations for customer governance calls.

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