The Medical Evidence Delivery Team within Oncology Business Unit (OBU) is responsible for strategic planning and operational delivery of interventional and observational AstraZeneca sponsored studies (AZ studies), externally sponsored scientific research (ESR) and early access programs (EAP) in order to generate the evidence to build confidence in and provide access to AstraZeneca therapies for patients in need. Specialist, Evidence Project Management (Spec EPM) will support the Associate Director, Evidence Project Management (AD EPM) and Manager, Evidence Project Management (Mgr EPM) in the operational delivery and oversight of company sponsored evidence studies and/or early access programs (EAP) to time, cost and quality. The Spec EPM works cross-functionally with internal and external partners to deliver certain aspects of the clinical study as delegated by the AD EPM/Mgr EPM and in accordance with the clinical outsourcing model (EMPOWER), current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices and in line with AZ values and behaviours. Responsibilities: Executes activities enabling AZ to fulfil sponsor oversight responsibilities and to maintain inspection-readiness, including - Maintain Study Inspection Readiness Tool - Coordinate and oversee periodic study-level TMF/Master File (MF) QC - Perform Periodic TMF/MF QC on behalf of Study/EAP Management - Customization of the study’s Expected Document List (EDL) in collaboration with the CROs - Collaborate with extended study team to develop, maintain, and execute activities according to the study Sponsor Oversight Plan - Ensure appropriate documentation of oversight and inspection-readiness tasks is maintained - Ensure handover documents are created, signed and filed in TMF - In collaboration with CRO, support creation, execution and maintenance of AZ TMF/MF Plan • Supports key study start-up activities, in collaboration with CRO and internal functions as needed - Internal system’s set up (VCV, SPOL, Shared mailbox, etc.) - D-code requests - Creation and maintenance of Study Team Charter / R&R document - Creation and maintenance of study team contact list - Creation and maintenance of Decision and Issue trackers Coordination & documentation of internal study team meetings - Provide input into development of study/EAP plans and study/program documents as needed • Support compliance and quality deliverables - Assist recording of QIs in VQV - Assist in audit/inspection preparation as needed - Monthly review of the data present in PharmaCM - Monthly review of workbooks • Create and maintain internal study/program trackers and systems as needed, including mailboxes and collaboration forums - Ensure new team members have access to all required systems • Enter/maintain accurate data relating to study/EAP scope and progress on all business systems throughout the course of study every month • Support budget management activities including - Raise POs - Maintain - Support invoice reconciliation • EAP program participation, status and tracking: - creation of country tracker aligned with agreed country participation timelines/exit strategy - creation and maintenance of study team contact list - creation and maintenance of Decision and Issue trackers - Provide program level tracking and updates - Validate source information for stakeholder reporting - Maintain SSI with approved protocol - US specific local operational requirements - Ensure EAP MF Archiving - Active participation in CRO operational governance meetings Requirements: Essential: ▪ Bachelor’s degree required preferably in medical or biological science or equivalent by experience ▪ Knowledge and understanding of the clinical study and drug development processes, GCP/ICH guidelines ▪ Excellent written and verbal communication skills as well as proven collaboration and influencing skills ▪ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities ▪ Demonstrated ability to collaborate as well as work independently ▪ Ability to effectively work with Clinical Research Organisations/External Providers ▪ Proven ability to interact widely and effectively within the company across regions, functions and cultures ▪ Ability to manage competing priorities Desirable: ▪ Advanced degree in medical or biological sciences or field associated with clinical research ▪ Proven organizational and analytical skills ▪ Previous administrative training/experience Date Posted 05-lis-2026 Closing Date 11-lis-2026 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 is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Specialist I/Specialist II, Evidence Project Management, Oncology.

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