Description
Manage local operational aspects of Investigator Sponsored Studies including: Drive local study operations (with investigator, study teams/medical directors, contracts) Facilitate ISS submissions, study performance, and ensure compliance to local regulations and procedures Lead local ISS review teams review of submissions (concepts, proposals, protocols) Local budget management, including forecasting & payments per contract to investigators Lead Quarterly Needs Assessment for ISS programs Provide product forecasts to Pharm Dev Request drug shipments from Commercial or R&D Supply Chain Liaise with local health agencies / alliances (e.g. NCI) Monitor SAE reporting Facilitate review of ISS Report/Manuscript Support audits Close & archive study Primary capability is DRIVING PERFORMANCE:Hold investigators accountable for fulfilling the terms of the contract, including recruitment updates, publications, and other deliverables Hold stakeholders accountable for following internal policies, HCP engagement guidelines, local regulations (eg CIA)