Clinical Study Administrator

Typical Accountabilities Study coordination and administration Assist the Local Study Team with the coordination and administration of clinical studies from start‑up through execution and close‑out. Act as the main local administrative contact and work closely with CRAs and/or LSAD for the duration of assigned studies. Coordinate administrative tasks during the study process, audits and regulatory inspections in line with company policies and SOPs. Document management and submissions Support the collection, preparation, review and tracking of documents required for the application process. Support the Study Start‑up team with timely submissions to Ethics Committees/Institutional Review Boards (EC/IRB) and, where applicable, Regulatory Authorities. Take operational responsibility for correct set‑up and ongoing maintenance of the local electronic Trial Master File (eTMF) and Investigator Study File (ISF), ensuring document tracking in accordance with ICH‑GCP and local requirements to maintain inspection readiness. Ensure all study documents are prepared for final archiving and support CRAs with ISF close‑out activities. Contribute to the production and maintenance of study documents, ensuring compliance with required templates and versions. Manage clinical‑regulatory documents in the Global Regulatory management system, as required. Manage clinical‑regulatory documents for electronic applications and submissions, complying with Submission Ready Standards (SRS) to support efficient publishing and delivery to regulatory authorities, where applicable. Contracts, payments and legal interactions Serve as primary point of contact for legal negotiations related to confidentiality agreements and amendments. Process study‑level and site‑level amendments. Prepare and/or support site‑level contract preparation, except where a specific local role is assigned. Prepare, support and perform payments to Health Care Organisations (HCO) and Health Care Professionals (HCP) in accordance with local regulations. Systems, tracking and materials Set up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. Clinical Trial Management System [CTMS]) and support others in the use of these systems, except in countries with a designated system administrator. Manage and contribute to the coordination and tracking of study materials and equipment. Interface with Data Management Centres and/or Global Clinical Solution representatives to support delivery of study‑related documents and materials. Stakeholder engagement and communication Interface with investigators, external service providers and Clinical Research Associates (CRAs) to facilitate effective document collection and study delivery. Lead practical arrangements for internal and external meetings (e.g. study team meetings, monitors’ meetings, investigators’ meetings), liaising with internal and external participants and vendors in line with applicable international and local codes. Prepare, contribute to and distribute material for meetings, newsletters and web content, in alignment with LST and global stakeholders. Perform document layout and language checks, as well as copying and distribution. Provide support for local translation and English language checks, as required. Handle printing and distribution of documents (e.g. letters, meeting minutes) and manage and archive study‑ and country‑related emails. Compliance Ensure compliance with AstraZeneca’s Code of Ethics, policies and procedures, including those related to people, finance, technology, security and Safety, Health and Environment (SHE). Adhere to all relevant local, national and regional legislation. Carry out additional country‑specific tasks in accordance with local organisational needs, when assigned. Education, Qualifications, Skills and Experience Education and experience Bachelors degree aligned to the knowledge and skills required for the role. 0 + experiencerequired Relevant knowledge of the drug development process, international guidelines (ICH‑GCP) and applicable country regulations. Role‑required skills Personal effectiveness and strong self‑accountability. Learning agility. Financial, technology and process competency. Active listening and fluency in written and spoken business‑level English. High integrity and ethical standards. Ability to work effectively as part of a team in both in‑person and virtual settings; demonstrates cultural awareness. Ability to identify and champion more efficient delivery of quality clinical trials with optimised cost and time. Ability to travel nationally and internationally, as required. Valid driving licence, if required by country of employment. Strong communication and teamwork skills, including collaboration, business partnering and impactful site conversations. Effective, risk‑based thinking, including planning and alignment, problem solving, critical thinking and decision making. Clinical study operations (GCP) and quality management, including Good Documentation Practice (GDP). Date Posted 20-may-2026 Closing Date 26-may-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr AstraZeneca GmbH