Bristol Myers Squibb Company

Global Clinical Operations Business Capability Lead - Protocol and Consent Management

Location
Princeton, NJ, United States
Posted
Sep 10, 2020
Ref
R1528774
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Profile Description:

The Clinical Trial Business Capability Lead (BCL), Protocol and Consent Management role will provide overall leadership and governance of a GCO business capability end-to-end, encompassing people, process and technology strategy implementation. The BCL will be acting as the primary point of contact and advisor for the business capability stakeholders across GCO through proper stakeholder engagement and management.Success in that role will require ensuring proper demand management, prioritization and evaluating process impact assessments of key change initiatives ensuring value is delivered through the business capability. The role is also accountable for executing the business capability governance and process strategy including the use of technologies and related systems in support of clinical trial research programs. The role also ensures effective alignment of Consent Management capabilities and processes with other business processes and regulatory requirements for inspection readiness. Specifically, this BCL role will own the Protocol and Consent Management capability, including technology systems and processes, and is accountable for compliance with key regulatory and quality requirements pertaining to the capability.

Aligned with our focus to put patients first, BMS aims to enable and simplify the protocol and consent management process in informing and enrolling a patient on a clinical trial. This role will be responsible in consolidating the vision of digitizing the clinical trial experience for patients and sites, in the ownership of a Protocol and Consent Management Business Capability, enhanced by digital capabilities.

Key Responsibilities and Major Duties

  • Serves as the Business Capability Lead/Subject Matter Expert for the business capability, including system/technology, regulatory inspection/internal audit.
  • Owns the governance strategy, roadmap, execution, and monitoring of the business capability
  • Effectively managing and engaging key stakeholders as per governance strategy to ensure business needs and requirements are met, prioritized and communicated.
  • Performs process impact assessments as needed to determine breadth and risks involved with proposed change initiatives
  • Ensures proper documentation and oversight of all business processes, standard procedures and technical instructions related to business capability ensuring compliance with regulatory requirements
  • Develop and implement operational support model and training delivery plan to support the evolving needs from a business process and system life-cycle management perspective.
  • Partners with IT to set and drive a clear roadmap for the business capability that includes proper demand management, release planning and release management of technology system(s)
  • Partners with the IT Business Partnering organization to ensure business needs are met and outcomes are delivered.
  • Partners with R&D functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of enhancement to current business capability
  • 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
  • Monitors and oversees business capability operational health and metrics
  • Embraces a culture of quality, compliance and data integrity to promote a state of inspection readiness for the business capability
  • Participate in audits and inspections for the business capability to ensure data requests by auditors and agencies are met


Requirements:

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 project management directing system, process, program or quality activities. 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
  • Experience with Electronic Informed Consent Forms best practices and principles
  • Experience with Protocol writing best practices
  • Experience with Legal, Regulatory and Compliance requirements with regards to the informed consent process and documentation
  • Understanding of Clinical Research Sites and Patients needs, challenges and opportunities in clinical trials
  • Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts
  • Ability to analyze and interpret complex issues and propose innovative 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.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.