Astrazeneca
StudyStartUpManager
“Study Start Up Manager at Astrazeneca. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, Clinical Study Management, study start-up. Driving site start-up activities. Ensuring timely and efficient delivery of site activation deliverables”
What You'll Achieve.
achieve quality and quantity targets; compliance with AZ Procedural Documents, international guidelines like ICH and GCP, and local regulations; timely and efficient delivery of site activation deliverables
Industry & Context.
Proactively identify delays in start-up activities and the risks to the activation plan
On-Site
What They're Looking For.
Must Have
3+ years of relevant experience, Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, Basic knowledge of GMP/GDP, Basic understanding of drug development process, Good collaboration and interpersonal skills, Good verbal and written communication skills, Excellent attention to details, Excellent understanding of Clinical Study Management and study start-up, Good negotiation skills, Good ability to learn and adapt to work with IT systems
Nice to Have
Advanced degree within the field, Professional certification, Understanding of multiple aspects within Study Management
What You'll Do.
Driving site start-up activities, Ensuring timely and efficient delivery of site activation deliverables, Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents, Assist in coordination and administration of clinical studies from start-up through site activation, Activate study sites in compliance with AZ Procedural Documents, Drive delivery of regulatory documents at the sites, Proactively identify delays in start-up activities and the risks to the activation plan, Primary reviewer of site level Informed Consent Forms, Update Veeva Clinical Vault (VCV) and other systems with data from centres as required per SAT process, Ensure regulatory binders and study supplies are provided for study site start-up and/or delivered as per SAT process and agreement with Local Study Delivery Team, Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA, Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health, and Environment), Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva), Ensure timely delivery of proper documents for support of study team submission to Regulatory Authorities, Ensure that all start-up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File, Contribute to the production of study start-up documents, ensuring template and version compliance, Create and/or import clinical-regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL, Set-up, populate, and accurately maintain information in AstraZeneca tracking and communication tools (e.
, Veeva, MS Teams, Box etc.
) and support others in the usage of these systems.
How You'll Work.
Team & Collaboration
Collaborate closely with Monitors, Support Services, Research sites, and the Local Study Delivery Team; Actively participate in local Study Delivery Team meetings; work cross-functionally with Contracts, Feasibility, and Study Support Services in US SM&M; Share information (metrics) on study site progress towards activation within local Study Delivery Team and US SM&M leadership as required; in liaison with local Study Delivery Team Lead and QA; support others in the usage of these systems
Communication Scope
Good verbal and written communication skills
Process & Methodology
Clinical Study Management, study start-up
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