Associate Director, Digital Data Flow and Clinical Data Standards Business Capability Lead (R1552288-en-us-1)
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.
The Clinical Trial Business Capability Lead (BCL), Digital Data Flow and Clinical Data Standards role will provide overall leadership and governance of a GDO 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 GDO 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 Digital Data Flow and Clinical Data Standards capabilities and processes with other business processes and regulatory requirements for inspection readiness. Specifically, this BCL role will own the Digital Data Flow and Clinical Data Standards 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 optimize protocol development by utilizing trends in enrollment, patient burden and known study timelines to simplify protocols and utilize best-in-class approaches for our clinical trials. This role will be responsible in consolidating the vision of the Digital Data Flow in digitizing the clinical trial build, simplifying protocols, enabling consistent data standards and improving access and experience for patients and sites to clinical trials.
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
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 Protocol Optimization and Feasibility best practices and principles
- Experience with Protocol development best practices
- Experience with Legal, Regulatory and Compliance requirements with regard to the informed consent process and documentation
- Understanding of Clinical Research Sites and Patient’s needs, challenges and opportunities in clinical trials
- Experience with Clinical Data Standards and CDISC
- Experience with Nurocor or other MDR system
- Experience with Electronic Data Capture, Database Development and Clinical Data Management best practices
- Experience with Regulatory requirements with regards to Clinical Data Management
- Understanding of challenges and opportunities in managing data within 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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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