Site Activation Team Specialist

Introduction to role:

This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.

Are you ready to make a difference in the world of clinical research? As a Site Activation Team Specialist (SATS), you'll play a pivotal role in the delivery of site start-up activities for assigned studies. Collaborate closely with Monitors, Support Services, Research sites, and the Local Study Delivery Team to ensure timely and efficient site activation. Your expertise will ensure that all requirements for site activation are met according to AZ Procedural Documents, international guidelines such as ICH and GCP, and relevant local regulations. With experience, you may even take on additional responsibilities associated with the Site Activation Team Leader (SATL) role.

Accountabilities:

• 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.

Additional Responsibilities:
• Contribute to process improvements, knowledge transfer, and best practice sharing.
• Actively share applicable information that may be relevant to other functions.

Essential Skills/Experience:

• Bachelor’s degree in relevant discipline
• Experience of Study Management within a pharmaceutical or clinical background
• Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management.

Desirable Skills/Experience:

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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by a vision to eliminate cancer as a cause of death. Our commitment to pioneering new frontiers in oncology research is unwavering. With cutting-edge science and technology at our fingertips, we aim to deliver breakthroughs that transform patient outcomes. Our collaborative research environment unites academia and industry, expediting progress against some of the toughest cancers. Join us on this exciting journey where courage, curiosity, and collaboration lead the way.

Ready to make an impact? Apply now to join our team!

Date Posted

06-nov-2025

Closing Date

19-nov-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.