Associate Director, Clinical Data Standards

1 day ago

Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time
Job Summary

Bristol-Myers Squibb is seeking an experienced Associate Director, Clinical Data Standards to lead our clinical data standards activities across multiple clinical development programs. As a key member of our Clinical & Safety Data Insights and Analytics team, you will oversee a team of standards professionals in planning, coordination, and timely delivery of global standards elements for study database consumption.

Key Responsibilities
  • Provide leadership and oversight to manage Standards Managers, determine resource requirements, prioritize assignments, and balance workload.
  • Develop and communicate data standards implementation strategy within the department and across functions.
  • Contribute to the development and application of smart systems and optimal approaches to support the end-to-end clinical trial data lifecycle, from collection through submission.
  • Ensure procedural documents are reflective of industry standards, easily followed, and regularly maintained.
  • Hold accountability to resolve issues and proactively develop solutions, within the functional and across functions.
  • Engage and energize employees through communication of goals, priorities, and other business-critical information.
  • Develop and promote a workplace culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability.
Requirements
  • Bachelor's degree required with an advanced degree preferred.
  • At least 12 years of global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices, including 3 years of line management experience.
  • Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition as well as analysis reporting in a global arena.
  • Strong knowledge of industry clinical data standards and processes (e.g., CDISC: CDASH/SDTM/ADaM, SDSP) and well-versed in industry best practice documentation from regulatory authorities (e.g., Technical Conformance Guide, Standards Catalog, CDISC TAUGs, etc.).
  • Strong knowledge of industry-leading eCRF tools (e.g., Medidata Rave, Oracle, etc.) and well-versed in industry trends and emerging technologies supporting end-to-end solutions for data collection through submission (e.g., Metadata Data Repositories, Data Warehouse, Clinical Data Repository).
  • Strong knowledge of GCP/ICH guidelines.
  • Technical expertise, technical writing ability, and experience in Systems Development Life Cycle (SDLC) principles.
  • Demonstrated partnership across various collaborative forums, CROs, SMOs, and/or local site networks.
  • Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality, etc.).
  • Influential leadership and communication capabilities with a proven ability to engage, manage, develop, and inspire a geographically diverse team.
What We Offer

Bristol-Myers Squibb is committed to creating a workplace culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Join our team and be part of a company that is dedicated to transforming patients' lives through science.

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