Bristol Myers Squibb Global Clinical Standards Team lead in Hopewell, New Jersey
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Within the Global Data Management and Centralized Monitoring organization, the Global Standards team works with stakeholders across BMS to ensure data is collected and delivered in a standardized manner to promote efficient and quality analysis and submissions. The Global Standards Team Lead will manage the team, providing functional oversight and career management and will be the primary contact point for internal and external stakeholders. The Global Standards Team Lead will also process a portion of the standards requests which are submitted.
Global Clinical Standards Team Lead is responsible for :
Lead the Global Standards Team work activities, including directing the work, optimizing the process/roles/tools, and making sure standards requests are being completed efficiently and effectively
Provide career management for the Global Standards Team members, developing team members and providing opportunities in line with their career growth
Lead collaborations with groups within Global Data Management & Central Monitoring (GDMCM) and with internal stakeholders to ensure standards are being evaluated, governed, and implemented effectively
Lead the efforts to evaluate industry best practices in the areas of study and data management, data tabulation and analysis & reporting, and identify standardization development or improvement opportunities.
Develop and maintain existing standards used in support of clinical trials managed internally and by external partners, primarily in Immuno-Oncology, including providing 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.
Partner with functional area stewards to establish and maintain processes for ensuring alignment across the data chain and associated systems.
Participate in GDMCM and company wide initiatives, including taking leadership proles in these initiatives as needed
Minimum of Bachelor’s degree required
5-10 years of experience in pharmaceutical industry of which 5 years have been in Clinical Data Management related to startup, conduct, and reporting for clinical trials.
Demonstrated ability to manage and lead high-performing multidisciplinary teams and build alignment across functional areas for both drug programs and continuous improvement projects.
In-depth 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.
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.
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.