Bristol-Myers Squibb Company

Clinical Data Operations Manager

Location
Princeton, NJ, United States
Posted
Apr 12, 2019
Ref
R1514282
Required Education
Bachelors Degree
Position Type
Full time
The Clinical Data Operations Manager is an associate director position within BMS. This leadership role will work directly with the Innovative Medicines Director of Data Operations to build and maintain a sustainable, flexible outsourcing model designed to deliver high quality clinical data resulting in successful marketing applications.

Responsibilities include but are not limited to:

• Serve as the sponsor data management primary contact for assigned projects.

• Manage performance and quality issues with CRO roles responsible for managing the clinical study patient data.

• Escalate issues and develop appropriate risk mitigation, as needed.

• Provide oversight to ensure data review and cleaning plan is comprehensive and executed by the appropriate roles at pre-defined intervals for assigned projects. Ensure documentation is inspection ready at all times.

• Participate in regulatory inspections and audits activities.

• Work collaboratively with internal and external functional leads and study team members to develop or modify existing guidance documents, work instructions, and SOPs as needed including Key Performance Indicators.

• Perform comprehensive review of clinical documents for critical studies in the portfolio, ensuring continuity of data elements between the protocol, data collection specifications (CRF and external data), data review and cleaning plans, statistical analysis and analysis presentation plan, and final CSR.

• Key contributor to the development of a portable end-to-end data integration plan based on TransCelerate and CDISC standards, including documentation of all data deliverables with the goal of having consistency within Innovative Medicines regardless of the clinical study data source.

• Key contributor to the development of a Sponsor Oversight Plan that meets the regulatory GCP requirements, ensuring CROs deliver quality databases on schedule. Plan will include requirements for inspection readiness.

• Execute or manage the tasks required by the Sponsor Oversight Plan.

• Develop strong and productive working relationships with key internal and external stakeholders

Required Qualifications:

• Bachelor's degree with 10 years of drug development experience in a pharmaceutical company.

• A minimum of 3 years working directly as a senior clinical data manager.

• Experience working at or with a CRO and/or an ARO.

• Strong working knowledge of CDISC data standards including end-to-end use from start-up through analysis (CDASH, SDTM, ADaM).

• Expert knowledge of clinical study data management tools (e.g. Medidata Rave, Oracle, MedDRA, WHODrug etc.).

• Demonstrated experience cleaning, interpreting, and analyzing clinical study subject data using industry standard tools (e.g. SAS, J-Review, Spotfire, etc.).

• Experience developing, improving and documenting processes including root cause analysis, requirement gathering, process maps, use of Visio and other Microsoft tools.

• Experience developing SOPs, guidance documents, work instructions etc.

• Demonstrated ability to take accountability for decisions and outcomes.

• Highly self-motivated, adaptable, and resilient with excellent time-management and written communication skills.

• Significant global clinical trial expertise with a successful track record of leading through influence, working across complex, global organizational matrices.