Study Start Up Manager

AstraZeneca

2d • Onsite

About The Position

Are you ready to take on a pivotal role in the Site Activation Team as a Study Start Up Manager? As a key player in the US study team, you'll be responsible for driving site start-up activities, ensuring timely and efficient delivery of site activation deliverables. Collaborate closely 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 also take on additional responsibilities as a Site Activation Team Leader. Are you up for the challenge?

Requirements

• Bachelor’s degree in related discipline with 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 Haves

• Advanced degree within the field
• Professional certification
• Understanding of multiple aspects within Study Management

Responsibilities

• 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.
• Actively participate in local Study Delivery Team meetings and work cross-functionally with Contracts, Feasibility, and Study Support Services in US SM&M.
• Activate study sites in compliance with AZ Procedural Documents.
• Share information (metrics) on study site progress towards activation within local Study Delivery Team and US SM&M leadership as required.
• 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.g., Veeva, MS Teams, Box etc.) and support others in the usage of these systems.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level