Global Clinical Standards Specialist
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. 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.
- Develop and maintain existing standards used in support of clinical trials managed internally and by external partners, primarily in Immuno-Oncology.
- 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.
- 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.