Senior Data Management Systems Programmer (Rave)

Description

Hybrid Working

At Astellas we recognize 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; optimizing the most productive work environment for you to succeed and deliver.

• Designing, developing and testing clinical study EDC databases (Medidata Rave) including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions.
• Maintaining all supporting documentation for studies/systems in accordance with processes to ensure quality, traceability, and compliance.
• Providing expertise in evaluating complex study requirements, determines feasibility of complex protocols, visit schedules/folders, and advises on best approaches and implementation.
• Tracking issues in Medidata applications, work with Medidata to resolve, and escalate issues appropriately to senior management.
• Assisting in management of user access to clinical databases using iMedidata & Cloud Administration.
• Assisting in managing and updating medical coding dictionaries, including but not limited to MedDRA and WHODrug.
• Overseeing any activities outsourced to CROs for database build or database edit check programming.
• Acting as subject matter expert (SME) in support for authoring or updating any departmental documentation (e.g., training documents, process guidance).
• Identifying and communicating lessons learned, best practices and frequently asked questions.
• Ensuring clinical database process efficiency, proactively identifies any gaps, and works with DM team to implement alternative processes as necessary.
• Monitoring Data Management key performance indicators for clinical database systems and develops action/escalation plans accordingly.
• Analyzing problems of high complexity; develops and implements alternative solutions both internally and with vendors.
• Participating in installation, validation, and implementation of new software or key system upgrades.
• Providing expert level technical direction to less experienced team members to ensure highest quality results.
• Educated to degree level or higher (equivalent) in Computer Science, Informatics, or life science discipline.
• Demonstrated previous experience in pharma or CRO industry in a senior informatics or programming role.
• Strong cross-functional understanding of processes of data management, clinical programming, biostatistics, and clinical operations, with high level of expertise expected in the DM systems discipline. Demonstrated experience in leading system selection and implementation projects.
• Experience in clinical trial database design and management with EDC and other data systems. Medidata Rave EDC, including Rave EDC Custom Function programming experience is preferred.
• Experience with pharmaceutical clinical research and clinical database development and Agile processes.
• Experience with database structures and programming languages.
• Strong working knowledge of Drug Development Process, Software Development Life Cycle, Computer Validation Process, and GCP regulations.
• Extensive experience with the development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.
• This is a permanent full-time position based in the UK.
• We offer a hybrid working pattern, requiring one day per quarter in the office (Addlestone), blended with a collaborative video environment that supports working from home.