Job Description

📌 New Opportunity at AstraZeneca! 📌

Join us as a Study Start Up Manager in the Site Activation Team at AstraZeneca! In this pivotal role, you will drive site start-up activities, ensuring the timely delivery of activation deliverables. Collaborate with Monitors, Support Services, Research sites, and the Local Study Delivery Team to achieve quality and quantity targets. Your expertise will ensure compliance with AZ Procedural Documents, international guidelines like ICH and GCP, and local regulations. With experience, you may progress to become a Site Activation Team Leader. Are you ready for this challenge?

Key Responsibilities:
– Obtain and maintain essential documentation in compliance with ICH-GCP and AZ Procedural Documents.
– Assist in coordinating and administering clinical studies from start-up through site activation.
– Participate in local Study Delivery Team meetings and collaborate cross-functionally with Contracts, Feasibility, and Study Support Services in US SM&M.
– Activate study sites in alignment with AZ Procedural Documents.
– Share study site progress metrics within the local Study Delivery Team and US SM&M leadership.
– Drive the delivery of regulatory documents at the sites.
– Identify delays in start-up activities and risks to the activation plan proactively.
– Review site level Informed Consent Forms.
– Update Veeva Clinical Vault (VCV) and other systems with center data per SAT process requirements.
– Ensure regulatory binders and study supplies are provided for study site start-up as per SAT process and agreement with the Local Study Delivery Team.
– Prepare for audit and regulatory inspections in collaboration with the local Study Delivery Team Lead and QA.
– Uphold compliance with AstraZeneca’s Code of Conduct and company policies relating to people, finance, technology, security, and SHE.
– Ensure completeness of the Study Master File for study start-up documents and site activation, and file essential documents in the TMF enterprise system (Veeva).
– Deliver proper documents in a timely manner to support study team submissions to Regulatory

Link to apply: https://lnkd.in/ew__vbxx