Job Details

Senior Clinical Database Programmer (RAVE)

  • £Competitive
  • UK, Ireland or the Netherlands, , - None Specified -
  • Permanent

A global pharmaceutical company is looking to hire a Senior Data Management System Programmer (Medidata RAVE) to join them on a permanent basis. This is a remote role, with a requirement to work on-site 1 day per quarter. Please note, applicants must be located in the UK, Ireland or the Netherlands.

Within this role, you will evaluate, develop, maintain, and support clinical data systems which are used to collect, review, and analyse data in phase I-IV clinical trials. You will lead and manage clinical database programming activities on multiple studies according to agreed processes, standards and timelines.

This is a unique opportunity to be part of a global data management team that collaborates in managing best practices and standards to maintain, enhance, improve, and innovate on efficient processes for clinical data systems programming.

Role Responsibilities:

  • Designing, developing and testing clinical study EDC databases (Medidata Rave) including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions.
  • Providing expertise in evaluating complex study requirements, determines feasibility of complex protocols, visit schedules/folders, and advises on best approaches and implementation.
  • Maintaining all supporting documentation for studies/systems in accordance with processes to ensure quality, traceability, and compliance.
  • Overseeing any activities outsourced to CROs for database build or database edit check programming.
  • Tracking issues in Medidata applications, work with Medidata to resolve, and escalate issues appropriately to senior management.
  • Assisting in managing and updating medical coding dictionaries, including but not limited to MedDRA and WHODrug.
  • Acting as subject matter expert (SME) in support for authoring or updating any departmental documentation (e.g., training documents, process guidance).
  • 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.
  • Analysing 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.

Person Specification:

  • 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.
  • 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.
  • 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 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.
Trish Kelly Principal Consultant in Clinical Data Management & Clinical Research

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