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.
As the performance analysis lead for clinical quality, you develop and deliver data-driven insights on the quality of trial operations for BMS's innovative pipeline. You partner with clinical operations, quality management, and regulatory teams to identify the key quality hypotheses to test, run analytic projects, and deliver actionable insights. You enhance metrics and benchmarks that measure and predict good clinical practice (GCP) compliance, quality and risks, and facilitate quarterly review of these important metrics. You evaluate and identify opportunities for continuous improvement based on comparative assessments with industry benchmarks & internal targets. Your analyses, insights and recommendations contribute to even more effective trial operations.
If you enjoy the complexity and richness of clinical operations and have a passion to use data to assess and predict trial quality, we look forward to meeting you!
Key Responsibilities and Major Duties
* Analyze clinical trial operational performance, with a focus on quality metrics at global and regional levels, evaluating performance relative to industry peers and targets * Participate in relevant Quality Management Initiatives & Councils to deliver data driven insights and develop key quality indicators that will predict risk or drive decisions on GCP compliance and other quality factors (including but not limited to amendments, deviations, site monitoring) * Proactively network and liaise with cross functional business stakeholders to identify, contextualize and deliver high value analytics and insights, while ensuring objectivity and consistency across the enterprise * Develop monthly, quarterly analytic reviews and deliver high-value analyses of trial quality according to needs of strategic and operational leaders * Perform diagnostic and descriptive analytics to identify performance trends, root cause assessments and identify areas of continuous improvement * Perform or guide predictive analytics to proactively identify analytical areas of risk and innovative predictive indicators * Develop and enhance quality monitoring analysis tools and provide regular insights to clinical operations and quality management teams * Coordinate annual clinical quality benchmarking programs
* 7+ years' experience in the pharmaceutical, CRO or healthcare industry * Experience in global or regional clinical operations or quality-related functions is preferred * Demonstrated ability to use data to drive decisions and answer key business questions * Deep understanding of clinical operations at global and regional levels * Demonstrated ability to independently evaluate and draw insights on quality metrics and interconnections with operational performance metrics * Thorough understanding of regulatory requirements & guidelines (e.g. ICH, GCP) and Corrective and Preventative Actions (CAPA) is ideal * Understanding of the application of advanced analytics, including predictive analytic modeling approaches related to structured and unstructured data is ideal * Experience delivering in a matrix organization, including articulating value propositions, balancing trade-offs and managing demand * Excellence in meeting facilitation and in both written and oral communication * Demonstrated ability to build relationships with executives and peers, including ability to negotiate manage stakeholder engagement * Ability to be flexible and adapt quickly to the changing needs of the organization
* Familiarity and direct experience with systems used to manage clinical trials and trial quality; e.g., clinical trial management systems (Oracle, Rave), EDC, site monitoring, document management * Excel (advanced proficiency) * Microsoft Office * Predictive analytic software or methodologies is a plus (SAS, R, data mining, visualization tools/techniques, SQL etc)
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.