Study Start Up Manager

Overview

The Study Start-Up Manager is pivotal at the country level, orchestrating start-up activities to align with AstraZeneca's procedures, local and international guidelines such as ICH-GCP, and relevant regulations. This role involves detailed preparation, review, tracking, and management of site regulatory documentation. The manager will also maintain and report on site performance metrics, collaborating closely with Clinical Research Associates (CRAs) and the Local Study Team to ensure efficient and timely study start-up activities.

• Manage and conduct start-up activities at the country level, ensuring compliance with AstraZeneca procedures and relevant regulations.
• Prepare, review, and track site regulatory documentation; maintain and report on site performance metrics.
• Collaborate with CRAs and Local Study Teams to ensure timely and efficient study start-up activities.

• Minimum of 3 years of current or recent full-time work as a Clinical Study Start-Up Lead.
• At least 1 year of hands-on experience with Veeva Vault.
• Demonstrated expertise in a lead start-up position with robust skills in communication, organization, and project management.

• Bachelor’s Degree in a related discipline, preferably in life science, or equivalent qualification.
• Excellent understanding of clinical trial processes across Phases II-IV and ICH GCP.
• Proficient in vendor management, with strong organizational and problem-solving skills.
• Strong negotiation and communication abilities.

At AstraZeneca, we are committed to being an inclusive employer and encourage applicants from all backgrounds to apply. We are ready to welcome someone who is entrepreneurial, thinks big, and is eager to work together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, join us in pushing the boundaries of science to deliver life-changing medicines.

Why AstraZeneca?

At AstraZeneca, we embrace opportunities for change to drive meaningful advancements. Our mission is clear: to deliver life-changing medicines and redefine possibilities in biopharma. By combining diverse perspectives, pioneering science, and ambitious ideas, we are transforming patient outcomes worldwide.

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We offer a competitive Total Reward program, including:

• Competitive base salary, annual bonus, and long-term incentives
• Generous paid time off program
• Comprehensive benefits package

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive team that represents a diverse group of backgrounds and perspectives, knowing that inclusion drives better outcomes. We welcome all qualified candidates and align with applicable laws regarding inclusivity and employment eligibility. Individuals with disabilities can request reasonable accommodations during the application or interview process, as well as for essential job functions.

The annual base pay (or hourly rate of compensation) for this position ranges from $ - $ USD Annual, either as annual base pay or as the hourly rate (annual base pay divided by 2080 hours). 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.

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