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Manager, External Clinical Trial Data Acquisition
Posted on 7/13/2022
INACTIVE
Locations
Seattle, WA, USA • Berkeley Heights, NJ, USA • Princeton, NJ...
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
Leadership
Writing
Requirements
  • Bachelors degree required with scientific or data integration disciplines preferred
  • At least 4 years of global clinical trial expertise with a focus on external clinical data acquisition
  • Good understanding of the drug development process and clinical trial start-up/execution. Proven expertise in external data acquisition processes and technologies
  • Solid knowledge of industry leading external data acquisition tools and well versed in industry trends and emerging technologies supporting data acquisition
  • Strong knowledge of GCP/ICH guidelines
  • Technical expertise, technical writing ability, and proficiency in Systems Development Life-Cycle (SDLC) principles
  • Demonstrated partnership across various collaborative forums
  • Demonstrated ability to self-start, be solution-oriented, collaborate effectively with other stakeholders, and be accountable for results
  • Potential need for periodic travel
Responsibilities
  • Developing the data collection strategy for external vendor/partner generated clinical trial data, championing consistency across programs and therapeutic areas
  • Serving as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level, managing the completion of study start up, amendment and post final changes
  • Creating external data transfer specifications, ensuring external clinical trial data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting
  • Identifying and resolving issues which may negatively impact study deliverables. Seeking support from leadership as needed
  • Following procedural documents when completing deliverables
  • Actively participating in continuous improvement activities, defining and implementing the changes required to create industry-leading capabilities
  • Supporting preparations and follow-up actions related to Health Authority inspections and internal audits
  • Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing services on behalf of BMS
  • Developing strong and productive working relationships with key stakeholders throughout GDMCM, GDO, and BMS
  • Representing the Company in interactions with key external partners as part of any committee or industry group
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company mission
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.