Clinical Data Standards Associate Director

2 weeks ago

Chard, Somerset, United Kingdom Vertex Pharmaceuticals Full time

Vertex Pharmaceuticals is seeking a highly skilled Clinical Data Standards Associate Director to join our Clinical Data Strategy & Management team.

About the Role

This is a unique opportunity to collaborate with cross-functional teams and drive the creation and implementation of clinical data standards and processes at Vertex.

  • Strategic Leadership: Ensure alignment with the CDSM Leadership Team and Clinical Data Standards Committee, and develop a comprehensive strategy for Vertex's data standards and processes.
  • Efficient Implementation: Drive the efficient implementation of new standards, ensuring high-quality and timely results.
  • Collaboration and Relationship Building: Build strong relationships across the organization and with FSP/CRO partners to support standards implementation.

Key Responsibilities:

  • Monitor industry-wide data standards and propose implementation plans.
  • Lead cross-functional standards initiatives and ensure coherence across the organization.
  • Develop and organize review/feedback on new/modified standard eCRFs, CRF Completion Guidelines, edit checks, and manual data reviews.
  • Develop a training strategy and ensure consistent training programs for standards.
  • Serve as project manager for CDSC meetings, managing requests for deviations from standards content and processes.

Requirements:

  • Advanced knowledge of clinical data standard library components and metadata.
  • In-depth knowledge of clinical data management and standard maintenance systems and processes.
  • Expertise in pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH, and ODM), HL7, etc.
  • 8-10 years of relevant work experience in the biotech or pharmaceutical industry or equivalent combination of education and experience.

What We Offer:

  • Total Rewards offerings, including inclusive market-leading benefits.
  • Flexibility and resources to support growth and aspirations.
  • Opportunity to work with a global biotechnology company that invests in scientific innovation.

Vertex is an Equal Employment Opportunity and Non-Discrimination Employer:

  • Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.

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