External Data Specification Manager, Data Management

Bristol-Myers Squibb Princeton, NJ

About the Job

Description:

Primary Responsibilities\:
  • Management of study start up activities for clinical data from external sources.
  • Drives (with the protocol team) the completion of the study start up activities related to data sourced both from the eCRF and external vendors.
  • Collaborates with the Data Management 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 level.
  • 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. 
  • Identifies any new external data types and develops them in conjunction with key stakeholders (e.g., Biomarker Leads, GBS, Global Standards). 
  • 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.
  • Functions as the primary contact with external vendor staff for protocol level electronic data
  • transfers.
  • This includes preparing data transfer specifications from standard templates and ensuring vendor provides data compatible with the clinical database management system to allow for data integration. 
  • Communicates and resolves data issues with vendor staff and Clinical Team as appropriate.
  • Demonstrates a strong understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project.
  • Proactively identify and resolve issues noted during study start-up which impact the overall timelines and informs the appropriate team members (e.g. Clinical Site Managers, Protocol Manager, Site Monitor, Medical Encoding Group, Global Clinical Data Support Group, Data Management Leads, Global Pharmacovigilence) and coordinates follow-up. 
  • Engages the Data Management Lead and/or Protocol Manager to assist in the resolution of more complex issues.
  • Understands how the issues of a single study can impact the overall project. 
  • Skillfully manages matrix relationships (e.g., Clinical Site Manager(s), Protocol Manager, Site Monitor, Data Management Lead) to monitor study progress and resolve issues at protocol level.
  • Skilled in the use of technology.
  • Is able to function independently in addition to coaching other team members within an environment that relies heavily on this knowledge for information and communication.
  • Effectively uses available tools to gather information needed to manage study activities and generate expected deliverables.
Qualification:
Requirements\:
  • 3-5 years of as a medical technologist in a clinical laboratory or as a clinical discovery researcher.
  • 3-5 years of clinical data management or related experience.
  • Knowledge of data review processes and Database Management Systems including eDC systems.
  • 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.
  • Strong analytical skills to facilitate detecting and resolving data problems encountered in clinical research studies.