Senior Data Specifications Manager

Bristol-Myers Squibb Princeton, NJ

About the Job

Description:

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).
Qualification:

Requirements\:

  • Bachelor’s degree preferred in one or more of the following disciplines or related fields\: Clinical Pharmacology; Life Sciences; Laboratory Sciences; Allied Health; Pharmacy; Nursing.  
  • 4-6 years years of extensive experience as a Protocol Data Manager or equivalent in the pharmaceutical industry;
  • Experience negotiating with and influencing others to meet challenging goals. 
  • Must be self-motivated, with the ability to follow through on assignments without direct supervision, very attentive to detail, capable at multitasking across projects and able to effectively contribute in a team environment.   
  • Experience working with vendors who supply clinical data in electronic format.
  • Strong analytical skills to facilitate detecting and resolving data problems encountered in clinical research studies.
  • Previous experience using project management techniques including prioritization methods and the ability to work on different projects simultaneously.
  • Previous experience working in a team environment within a matrix organization.
  • Experience in effective implementation of data review/management plans/documents and document preparation.
  • Experience in all aspects of data management from CRF design to database lock within expectations set by management.
  • Experience in training less experienced data managers in system and study specific areas.
  • Knowledge of data review processes and Database Management Systems including eDC systems.
  • Knowledge of ICH-GCP guidelines regulatory guidelines/regulations.
  • Solid understanding of regulations, GCPs, 21CFR Part 11 and data privacy as they apply to data handling and the use of computer systems in clinical research.
  • Knowledge of general clinical research including Investigator site processes.
  • Knowledge of the pharmaceutical industry including the clinical and regulatory components.
  • Knowledge of basic project planning and management methods.