Clinical Global Standards Specialist

Hopewell, NJ, USA
Dec 06, 2017
Jan 06, 2018
Medicine, Medical
Contract Type
Full Time
Job Type
Other job types
Shares the vision for global standards strategy targeted to improve organization productivity, consistency, and quality while maintaining an innovative and flexible mindset to ensure study milestones are met (e.g. FPFV, DB Lock). Understand the complex and interdependent relationships between protocol development, data collection and analysis and reporting. Participates in standards governance by working in a fast paced, matrix environment providing recommendations and decisions on clinical and analysis related issues.

Responsibilities include:

• Develop and maintain existing standards used in support of Immuno Oncology trials managed internally and by external partners.

• Partner with functional area stewards to establish and maintain processes for ensuring alignment across the data chain and associated systems.

• Evaluate industry best practices in the areas of study and data management, data tabulation and analysis & reporting, and identify standardization development or improvement opportunities.

• Provide recommendations on changes or new standards to data chain co-chairs taking into account various stakeholder needs while ensure regulatory and BMS best practices are followed.

Job Requirements

• Minimum of Bachelor's degree with 5-10 years of experience in pharmaceutical industry of which 5 years have been in Clinical Data Management and/or Analysis & Reporting areas.

• Experience in the management of clinical trials including startup, conduct, and reporting activities.

• Experience in Industry Standards (e.g. CDISC) in either the collection (CDASH), tabulation (SDTM) or analysis (ADaM) models.

• Experience interpreting Health Authority regulations with a strong compliance background.

• Broad experience in various clinical database tools and applications for data collection, review, and the production of tables, listings, and graphs.

• Knowledge of data integration strategies and practices in support of external partnerships, strategic sourcing, and third party data acquisition.

• Demonstrated ability to lead high-performing multidisciplinary teams and build alignment across functional areas for both drug programs and continuous improvement projects.

• Skilled in project planning and management including resourcing, risk assessment, crisis management, and timeline projections.

• Strong negotiation and collaboration skills with ability to drive resolution of complex issues.

• Experience with Medidata Rave is a plus.

We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.