Study Start Up Manager

AstraZeneca•Wilmington, DE

31d

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? At AstraZeneca, we are driven by a bold vision to eliminate cancer as a cause of death. Our commitment to pioneering new frontiers in Oncology is fueled by cutting-edge science and technology. We empower our teams to make fearless decisions, take smart risks, and lead at every level. With a collaborative research environment that unites academia and industry, we are dedicated to improving the lives of millions affected by cancer. Join us on this exciting journey where courage, curiosity, and collaboration are at the heart of everything we do. Ready to make an impact? Apply now to join our team!

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

The annual base pay for this position ranges from $105,735.20 - 158,602.80.
Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours.
Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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