Associate Director, Clinical Data Standards

2 days ago

Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time
Transforming Patients' Lives through Science

Bristol Myers Squibb is a global biopharmaceutical company that is committed to transforming patients' lives through science. We are seeking an experienced Associate Director, Clinical Data Standards to join our team.

Job Summary

The Associate Director, Clinical Data Standards will be responsible for leading the development and implementation of clinical data standards across multiple clinical development programs. This role will oversee a team of standards professionals and ensure the timely delivery of global standards elements for study database consumption.

Key Responsibilities
  • Provide leadership and oversight to the clinical data standards team
  • Develop and implement clinical data standards strategies
  • Manage the book of work for global standards requests
  • Assign resources to standards requests and initiatives
  • Forecast future resource needs based on the book of work
  • Provide ongoing feedback, coaching, and career development to staff
  • Empower and hold staff to high-quality performance and delivery
  • Ensure procedural documents are reflective of industry standards
  • Contribute to the development and application of smart systems and optimal approaches to support the end-to-end clinical trial data lifecycle
  • Hold accountability to resolve issues and proactively develop solutions
  • Actively participate in and/or lead continuous improvement activities
  • 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
  • Ensure effective quality oversight and management of external partners performing standards activities on behalf of BMS
  • Develop strong and productive working relationships with key stakeholders throughout GDMCM, GCO, Global Biometrics & Data Sciences, and BMS
  • Represent the Company in interactions with key external partners as part of any committee or industry group relating to data standards
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
  • 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 providing a work environment that is inclusive, diverse, and supportive of our employees' growth and development. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

We are an equal opportunity employer and welcome applications from qualified candidates who are passionate about transforming patients' lives through science.

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