Senior Site Activation Partner - FSP

ExecuPharm a PAREXEL company are currently recruiting for a Senior Site Activation Partner to be dedicated to one of our clients in Mumbai. This is a permanent office and home-based position.

Role Overview :

The Senior Site Activation Partner is responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and GCP standards.

Responsibilities: Completion of critical information for site activation including Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status. Support local IRB workflow from submission through approval and support reporting of updates to safety information. Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1 revisions, for internal regulatory approval within required timelines. Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed. As required conduct or oversee investigator site activation activities including site budget and contract negotiation and facilitate site payments. May conduct remote monitoring activities, with a focus on Trial Master File/Site Master File reconciliation, investigational product reconciliation or other technical or logistical supportive activities. QualificationsThe successful candidate will have: circa 6 years experience in study activation and site management from a pharmaceutical / biotechnology or CRO environment. Knowledge of global and local regulatory requirements Demonstrated understanding of key operational elements of a clinical trial (e.g., study start-up, conduct, close-out activities, reporting. CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience or CRA, Reg Affairs. Must be fluent in English.