Data Management Systems Lead About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: As a Data Management Systems Lead, you will support end-to-end activities for programming and configuring Astellas’ systems, with a focus on system setup, data validation, reports, and analytics programming, across global studies and at a standard level. As part of a global data management team, Data Management Systems Lead will support multiple systems within the team (e.g., EDC, reporting and visualization tools, clinical repositories, central monitoring tools (CMT). Hybrid Working: At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver. Key Responsibilities: Manages (create, update, support) system setup of studies using system and study specific configurations, templates, and standards. This includes data mappings, reports programming, analytics programming, study setup, system configurations, and applicable documentation (e.g., technical specifications, approval forms). Performs EDC database build activities as needed and troubleshoots study build issues and/or system integration issues (e.g., eCRFs, change requests, edit checks, special actions/functions, derivations, interface configuration). Creates, tests, and supports user acceptance testing (UAT) for all study-level data checks and Rave system reports, as specified by the Lead Data Manager. Configures and maintains study level components and modules (e.g., EDC data imports, external data imports and exports, study setup). Provides technical solutions to end users and stakeholders to support their challenges, understand the current state and requirements, and provides well-informed and innovative alternatives and solutions. Essential Knowledge & Experience: Proven experience in pharma or CRO industry in an informatics or programming role. Advanced-level experience of clinical trial database design and management with EDC and other data systems. Medidata Rave EDC, including Rave EDC Custom Function programming experience highly preferred. Experience writing, programming, or configuring data validation checks and QC, UAT, platform testing, and writing and executing test scripts. Experience with database structures and programming languages and with eCRF design and specifications development. Advanced-level experience with T-SQL or PL-SQL programming and experience with SAS programming. Preferred Experience: Previous experience with the Clue Points system. Education/Qualifications: BS or MS degree in Computer Science, Informatics, or life science discipline or equivalent. Additional Information: This is a permanent full-time position based in the UK. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Addlestone office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.