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Clinical Data Strategies Consultant

Location: Wayne, PA
Status: Full-time, employee
*Local Candidates preferred. Must be able to work unrestricted in US. No Agencies please.

Currently, we have a career opportunity that involves consulting with clients on the development of a strategic vision for lifecycle-wide use of CDISC Standards and subsequent systems analysis/design services to implement that vision. 

We are seeking candidates with the following knowledge and experience: 

  • Good knowledge of the clinical data lifecycle, the use of CDISC Standards in that lifecycle, and industry tools to support data flow through the lifecycle
  • In-depth experience working in at least one area of the clinical data lifecycle
  • Good knowledge of the CDISC SDTM
  • Background knowledge of the other CDISC Standards (ODM, ADaM, LAB, Protocol Representation)
  • Regulatory Submissions knowledge, especially about data submission requirements
  • Strong biopharmaceutical/pharmaceutical references
  • Refined consulting skills
  • Ability to work independently, but also be part of a team
  • High level of communication skills and ability to interact with clients at various levels within a project

Reporting directly to the Senior Director of Clinical Data Strategies, the Consultant’s primary responsibilities will include the following:

  • Lead or collaborate on client consulting projects dealing with the assessment, design, and/or implementation of CDISC Standards and standards-based processes. These projects may include developing the following:
    • An Assessment and Gap Analysis
    • A Roadmap to define the strategic vision
    • A Conceptual and Functional Design for processes/systems
    • Time and resource estimates
    • A definition of a Standards Governance Framework
    • An inventory of standards metadata required in a Metadata Repository
  • Presentations on CDISC and CDISC related topics, internally as well as within the industry
  • Participation on a CDISC Standards team
  • Ability to work in flexible work environments including the Octagon office, a home-based office, and/or occasional onsite client location
  • Willingness to travel up to 20%

Octagon is an Equal Opportunity Employer with an outstanding corporate culture.  Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.

To apply for this position, please click here.