Global Clinical Operations Business Capability Lead - Electronic Data Capture

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), Electronic Data Capture (EDC) Capabilities role will provide overall leadership and governance of a GCO business capability end-to-end, encompassing 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 systems/technologies with other business processes and regulatory requirements for inspection readiness. Specifically, this BCL role will own the Electronic Data Capture 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 collect data from patients in an effective and compliant manner, our focus on a comprehensive Electronic Data Capture capability governance aims at solidifying our Clinical Trial Data strategy, streamlining Clinical Data Management processes and enabling BMS’s vision of being clinical trial sponsor of choice. This role is responsible for the overall leadership of the EDC capability including operational governance of our EDC platforms (RAVE, OC), enabling Data Management best practices, governing vendor relationships and supporting internal stakeholders adoption.

 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.
• Leads development of a connected experience for Data Management stakeholders, investigators and site staff to support Clinical Data Capture best practices before, during and after trial completion.
• 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 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
• Works broadly across Global Clinical Operations, Global Clinical Development, Global Data Management, Centralized Monitoring, Regional Clinical Operations, Clinical Trial Strategy, Quality & Compliance, IT, to leverage digital expertise and capabilities across the enterprise.
• 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 8 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.  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 Data Capture (EDC) best practices and principles including Medidata RAVE EDC and Oracle Clinical, including several modules in those platforms to support data capture, safety reporting, central monitoring, clinica data reporting.
• Experience with Regulatory and Compliance requirements with regards to the Clinical Data Management
• Understanding of challenges and opportunities in managing data within clinical trials
• Understanding of Clinical Data Management and Clinical Development stakeholder 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 project and matrix 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.