Senior Clinical Research Associate II

Typical Accountabilities: • Collects reviews and tracks regulatory and other relevant documents • Initiates and maintains production of documents, ensuring template and version compliance • Creates and/or imports clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GEL • Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities • Leads administrative appendices for the CSR • Provides input into non-drug project work including training activities and development of procedures as needed • Monitors the set-up and maintenance of information in AstraZeneca tracking and communication tools (e.g. IMPACT, Clinical Partners Portal and eRoom) and support others in the usage of these systems • Manages and coordinates tracking of study materials and equipment • Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs • Leads the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors • Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites • Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration Typical People Management Responsibility (direct / indirect reports): • Approximate number of people managed in total (all levels) - What is the global remit? (how many countries will the role operate in?): • 2 or 3 countries at a minimum of 40% of time Education, Qualifications, Skills and Experience: • Essential: Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers; Ability to develop advanced computer skills to increase efficiency in day-to-day tasks; Proven organizational and analytical skills; Ability to prioritise and manage multiple tasks with conflicting deadlines; Excellent knowledge of spoken and written English; Good interpersonal skills and ability to work in a team environment; Excellent verbal and written communication and presentation skills; Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities; Ability to prepare presentation materials • Desirable: Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines; Demonstrate ability to work independently, as well as in a team environment; Willingness to travel both domestically and internationally; Proactively identify risks and possible solutions; Demonstrate analytical thinking, concern for standards, concern for impact, good team skills including cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control, tenacity conflict resolution skills and the ability to influence others; Develop knowledge of therapy area through experience and review of scientific literature; Demonstrate professionalism and mutual respect; Willingness and ability to train others on study administration procedures; Passion for customers; Act decisively; Drive performance; Work collaboratively Key Relationship to reach solutions: • Internal (to AZ or team): Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate • External (to AZ): External service providers; Marketing Company personnel Date Posted 20-1月-2026 Closing Date 26-1月-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.