上海招聘

Key Responsibilities:

• As a primary point of contact between responsible sites and Everest, responsible for site start up activities, including but not limited to site identification and selection, preparation and submission of GCP/EC submission dossier, communication with site investigators, GCP officers and EC members, site contract negotiation and sign-off, coordinate HGRAC submission, etc.
• Take leadership of site management for the initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH-GCP, company SOPs and protocol requirements to ensure data quality, study subject protection, and site delivery that site recruitment, data entry and clean on time and within budget.
• Involving in quality control process, including but not limited to study file QC review, co-monitoring visits etc.
• Site issue management and escalation to management team if applicable.
• Site close-out activities, especially support final study file archive at the site, self-check, final site payment reconciliation, final study drug return, etc.
• Support project manager on other assigned study activities if applicable.

Our mission is to build a preeminent biopharmaceutical organization to develop and commercialize globally innovative products in Greater China and other emerging Asia Pacific markets.

Our advantage includes an insight-driven, highly productive business development engine and world-class clinical and regulatory teams, supported by a substantial financial foundation.