Data Specifications Manager

Bristol-Myers Squibb Princeton, NJ

About the Job


Primary Responsibilities\:
  • This position supports data management activities to ensure efficiency and quality throughout startup of the clinical trial from protocol development to database in production for both eCRF data and external data requirements.
  • Drives (with the protocol team) the completion of the study start up activities (e.g. CRF, Database Specifications, Derivations, External Data Specifications, etc.) and ensures program level standards are applied at the protocol level from study start-up to database in production.
  • Collaborates with the Data Lead to develop standards and ensure consistency and efficiency of the clinical protocols within indication or program for study startup standards and documents.
  • Drives and owns the timelines and associated deliverables and serves as the Global Standard Subject Matter Expert at the study and TA level.
  • Identifies any new external data types and develops them in conjunction with key stakeholders (e.g., Biomarker Leads, GBS, Global Standards); Develops and maintains the Study Matrix which outlines all of the collection requirements at the program/protocol level.
  • Oversees the vendor deliverables for external data. Drives the development of the database in collaboration with data base designer and Global Biometric Sciences.
  • Reviews the protocol to identify data collection needs. Remains critical to the protocol development and review process to ensure the most efficient data collection strategy is implemented.
  • Develops new data collection modules following the New Build Process.
  • Finalizes the Data Specifications Package, which are the specifications used to build the electronic Case Report Form (eCRF), visit schedule and derivations.
  • Develops the electronic Case Report Form (eCRF) which is the activated clinical production database.
  • Assists with vendor relations (e.g., CRO; CCL) as needed to support the incumbent’s project(s).
  • Leads cross functional teams or initiatives.
  • Bachelors (BS, BA)
  • 1-3 years of clinical data management or related experience.
  • Medidata RAVE experience.
  • 1 to 3 years of experience handling external source electronic data in the pharmaceutical industry.
  • Requires strong interpersonal, communication, planning, organization, negotiation, influencing, collaboration and presentation skills.