Bristol-Myers Squibb Company

Global Clinical Operations Business Capability Lead - Strategic Monitoring

Princeton, NJ, United States
Jun 24, 2019
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global bio-pharmaceutical 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.

The Business Lead role will provide overall leadership of system/technology projects (End-to-End process) acting as the primary point of contact and adviser for the business users of the system. Accountable for business process strategy and use of data technologies and related systems in support of clinical trial research programs. Ensures effective alignment of systems/technologies with other business processes and regulatory requirements for inspection readiness.

Key Responsibilities and Major Duties
  • Serves as the Business Lead/Subject Matter Expert for the system/technology including point of contact for regulatory inspection/internal audit.
  • Drives development, execution, and monitoring of the system/technology Business Plan in collaboration with key stakeholders.
  • Partners with Global Clinical Operations functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of new and existing platform capabilities.
  • Accountable for system/technology performance, project budget, stakeholder communications/change management, resolution/mitigation of issues and risks.
  • Oversees system/technology work streams and outcomes.
  • Contributes to internal/external continuous improvement initiatives.
  • Monitors new technologies and external trends to ensure BMS is leveraging the best of what is available

  • Bachelor's degree required with an advanced degree preferred.
  • Minimum of 3-5 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) activities plus 1-2 years in a leadership position directing system, process, program or quality activities.
  • Experience with Site Monitoring practices and principles, Centralized and Remote Monitoring and Risk Based Monitoring best practices is highly preferred
  • Significant, demonstrated breadth of experience, versatility, and independent leadership and stakeholder management skills
  • Experience in clinical trial, data, or technology management
  • Knowledge of GCP/ICH guidelines, regulations and procedures/policies
  • Ability to analyze and interpret complex issues and propose solutions
  • Experience with leading teams and driving innovation
  • Strong project management and planning skills
  • Effective oral and written communication skills to influence, inform, or guide others
  • Ability to effectively respond to regulatory trends, internal audits, inspection activities including root cause analysis/Corrective Action/Preventive Action (CAPA) plans for any findings.
  • Experience working in a matrix environment.