Global Clinical Trial Business Capability Lead Trial Transparency amp Disclosure Capabilities

Profile

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.

Profile Description

The Clinical Trial Business Capability Lead (BCL), Trial Transparency & Disclosure Capabilities role will provide overall leadership and governance of a GDO 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 Global Drug Development through proper stakeholder engagement and management.Success in this 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 Trial Transparency & Disclosure capabilities, including technology systems such as Clinical Trial Registration & Results (CTRR) and processes, and is accountable for compliance with key regulatory and quality requirements pertaining to the capability.

By adhering to local, regional, and national requirements for clinical trial disclosure, BMS is committed to publicly sharing information on the clinical trials we conduct, regardless of the outcome. We also believe in providing access to clinical trial information to researchers who seek to advance science in alignment with the PhRMA and EFPIA Principles for Responsible Clinical Trial Data Sharing and support enhanced transparency and sharing of clinical trial data with researchers, clinical trial participants, regulators and patient advocates. BMS is committed to honor legitimate requests for our clinical trial data from qualified researchers by providing access that also protects patient privacy, respects the integrity of global regulatory systems and maintains incentives for those who invest in biomedical research. CTRR as well as other technology solutions are used to achieve these transparency and disclosure commitments.

This role is responsible for the overall leadership of the Trial Transparency and Disclosure Capabilities.

Key Responsibilities and Major Duties


Serves as the Business Capability Lead/Subject Matter Expert for the business capabilities, including system/technology, regulatory inspection/internal audit.
Leads development of an optimized capability for registration and result disclosure according to current global regulations.
Leads the implementation of a data sharing capability to enhance the experience of researchers seeking clinical trial data for secondary research.
Owns the governance strategy, roadmap, execution, and monitoring of the business capability
Effectively managing, partnering and engaging with internal and external key stakeholders as per governance strategy to ensure business needs and regulatory 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 work instructions related to business capability ensuring compliance with regulatory requirements
Develop and implement operational support model, communication plan and training delivery plan to support the evolving needs from a business process and system life-cycle management perspective.
Partners with IT and platform providers (SaaS) 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 Development Operations, Global Clinical Compliance & Continuous Improvement, Medical, Commercial, IT, Public Affairs and Legal to leverage digital expertise and capabilities across the enterprise.
Accountable for system/technology performance, analytics/metrics, 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 and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation)
Knowledge of PhRMA/EFPIA principles of clinical trial disclosure, and related best practices
Experience with Clinical Trial Disclosure software solution(s)
Understanding of the patient experience and perspective 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.


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.

Company: Bristol-Myers Squibb

Req Number: R1526317_EN

Updated: 2020-06-11 00:00:00.000 UTC

Location: Princeton,New Jersey

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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