Data Management Systems Lead

5 days ago

Addlestone, United Kingdom Astellas Europe Full time
About Astellas Europe

Astellas Europe is a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing 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 healthcare 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.

The Opportunity

We are seeking a Data Management Systems Lead to 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, the Data Management Systems Lead will support multiple systems within the team, including EDC, reporting and visualization tools, clinical repositories, and central monitoring tools.

Key Responsibilities
  • Manage system setup of studies using system and study-specific configurations, templates, and standards, including data mappings, reports programming, analytics programming, study setup, system configurations, and applicable documentation.
  • Perform EDC database build activities as needed and troubleshoot study build issues and/or system integration issues.
  • Create, test, and support user acceptance testing (UAT) for all study-level data checks and Rave system reports, as specified by the Lead Data Manager.
  • Configure and maintain study-level components and modules, including EDC data imports, external data imports and exports, and study setup.
  • Provide technical solutions to end-users and stakeholders to support their challenges, understand the current state and requirements, and provide well-informed and innovative alternatives and solutions.
Essential Knowledge & Experience
  • Proven experience in the pharma or CRO industry in an informatics or programming role.
  • Advanced-level experience in clinical trial database design and management with EDC and other data systems, including Medidata Rave EDC and Custom Function programming experience.
  • 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, including T-SQL or PL-SQL programming and SAS programming.
Preferred Experience
  • Previous experience with the Clue Points system.
Education/Qualifications
  • BS or MS degree in Computer Science, Informatics, or a 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, requiring a blend of home and a minimum of 1 day per quarter in our Addlestone office.

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