·         Designs and oversees the relationship between the BMS Clinical Protocol Team and the external data source.
·         Coordinates, across multiple protocol/programs, the review, query, and edit of all electronically-sourced clinical data as well as laboratory data collected on Case Report Form (CRF).
·         Develops data specifications, coordinates sponsor/vendor data transmission, and assesses/resolves data quality issues as needed.
·         Performs standard startup activities for a new Phase IIa to IV study starts.  Tasks include protocol review, CRF review, database review, creating data transfer specification packages, and vendor requisition form review. 
·         Reviews all protocol-related study documents to ensure that data collection adheres to BMS standards. Resolves data issues with vendor and/or BMS study teams as appropriate.
·         Resolves data issues with Vendor and BMS Project teams as appropriate.  Documents issue resolution (as well as any open issues) according to BMS policies.
·         Participates in development and implementation of global EDO operating procedures and monitors the work of the EDO project team to ensure product quality.
·         Communicates to and collaborates with Data Specialists, Clinical Scientist or Protocol Managers, Protocol Data Managers, Protocol Biostatisticians, Protocol Programmer, Protocol Medical Leads, and Vendor Project Team.
·         Participates in training, development and mentoring of External Data Coordinators. Represents External Data Operations (EDO) at study team meetings.
·         Performs other tasks as assigned.


·         Bachelor's Degree in Life Sciences or related field required.
·         4-6 years experience in clinical trial data management, or 2-4 years experience in vendor data management. Will consider experience as a Medical Technologist in a clinical laboratory or as a researcher in Clinical Discovery as equivalent.
·         Functional use and understanding of clinical research and clinical database management systems (i.e. Oracle Clinical, Clintrial, etc.) and reporting tools (i.e. IReview, SQL, SAS, MS Access, etc.) preferred.
·         Understanding of relevant GLP, GCP 21CFR Part 11 and data privacy regulations as they apply to handling of clinical data.
·         Prior experience working with vendors who supply clinical trial data in electronic format preferred.
·         Incumbent must be self-motivated with a keen attention to detail and possess strong communication and analytical skills.
·         Must demonstrate the ability to effectively coordinate multiple concurrent projects in a complex, changing and sometimes challenging environment.
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