Clinical Data Strategy Director

4 weeks ago


Étreux, Hauts-de-France, United States Vertex Pharmaceuticals Full time

Job Summary

Vertex Pharmaceuticals is seeking a highly skilled Clinical Data Strategy Director to join our Clinical Data Strategy & Management team. As a key member of this team, you will be responsible for overseeing Vertex's standards for data collection and cleaning, as well as associated processes. This role requires a strong understanding of clinical data management and standard maintenance systems and processes.

Key Responsibilities

  • Monitor industry-wide data standards and propose concrete plans for implementation
  • Lead cross-functional standards initiatives and ensure coherence of standards initiatives across the organization
  • Develop and organize review/feedback on new/modified standard eCRFs, CRF Completion Guidelines, edit checks, manual data reviews, etc.
  • Work collaboratively with cross-functional leadership to identify and develop streamlined and compliant CRFs in new therapeutic areas
  • Develop strategy and standards library to ensure alignment to standards across systems
  • Provide mentoring and technical guidance to Start Up Group
  • Develop training strategy and ensure consistent training program for standards
  • Conduct periodic review and development of metrics to assess standards utilization and development trends
  • Serve as project manager for CDSC meetings

Requirements
  • Advanced knowledge of all clinical data standard library components and metadata across data collection, analysis, and reporting
  • In-depth knowledge of clinical data management and standard maintenance systems and processes, analysis, and reporting principles
  • Proven track record in identifying and implementing organization-wide initiatives, standards, and processes
  • Proven track record in managing global, cross-functional standards and processes
  • Knowledge of medical and statistical terminology
  • Expert in pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH, and ODM), HL7, etc.

Education and Experience
  • BS/BA or MS in a life science or analytical area
  • 8-10 years of relevant work experience in the Biotech or Pharmaceutical Industry, or the equivalent combination of education and experience


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