Study Start Up Manager

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 accelerate site activation so patients can access groundbreaking cancer trials sooner? As a Study Start Up Manager, you will turn complex regulatory and operational requirements into a predictable, high-quality path to site activation.

You will be a key driver in moving our ambitious pipeline forward, ensuring study sites are activated on time and to the highest standards of ICH-GCP and company procedures. Your work will directly reduce start-up bottlenecks and help advance multiple indications across a diverse portfolio, supporting our goal to bring several novel therapies forward.

Working within the local Study Delivery Team and partnering closely with Contracts, Feasibility and Study Support Services in US SM&M, you will connect strategy with execution, use data to inform decisions, and align stakeholders around clear activation milestones. How will you use your expertise to remove barriers and shorten activation timelines?

Accountabilities:

- Obtain and maintain essential documentation in compliance with ICH-GCP and 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 per 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.

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 team is dedicated to pioneering new frontiers in Oncology, fusing cutting-edge science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we are empowered to lead at every level. We make bold decisions driven by patient outcomes, collaborating seamlessly with academia and industry to expedite research in some of the hardest-to-treat cancers. Join us in making a meaningful impact on millions of lives.

Ready to take the next step in your career? Apply now and become part of our dynamic team!

Date Posted

Closing Date

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.