Global Biospecimen Management
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), Global Specimen Management role will provide overall leadership and governance of the Biospecimen, and Imaging Management (GBSIM) business capabilities related to technology development and strategy implementation. The BCL will act as the primary point of contact and advisor for the business capability stakeholders (primarily within GBSIM) through proper stakeholder engagement and management. Success in the 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 specimen management. The role also ensures effective alignment of on-going Specimen Management capabilities and processes with other business processes and regulatory requirements for inspection readiness. Specifically, this BCL role will own the Specimen Management capabilities, including technology systems and processes, and is accountable for compliance with key regulatory and quality requirements pertaining to the capabilities.
The Specimen Management capabilities leverage a suite of technology systems and business processes aimed at the end-to-end management of the lifecycle of clinical specimens (including both biospecimens and digital specimens) obtained by BMS for research and development. The domain of responsibility includes capabilities and solutions focused on the documentation of the sample journey in clinical trials, platforms for inventory and consent status, and the visualization of sample and clinical trial participant metadata.
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.
- Owns oversight of the governance strategy, roadmap, execution, and monitoring of the business capabilities
- 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 capabilities 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 capabilities 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 correctly interpreted, actioned upon 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 capabilities
- Accountable for system/technology performance, project budgets, stakeholder management and the resolution / mitigation of issues and risks
- Establishes effective communication channels to enable the transparent flow of information between capability leaders, stakeholder groups and support teams
- Emphasizes consistency and facilitates the use of Change Management tools and techniques, ensuring leaders, line managers, users and change practitioners fulfill their responsibilities to support each impacted stakeholder through the change journey
- 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 capabilities operational health and metrics
- Embraces a culture of quality, compliance and data integrity to promote a state of inspection readiness for the business capabilities
- Participate in audits and inspections for the business capabilities to ensure data requests by auditors and agencies are met
- Maintains timelines, monitors investment spend and regularly reports out to stakeholders on status and issues
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. 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 biospecimen management best practices and principles
- Experience with imaging management best practices
- Experience with global and regional Legal, Regulatory and Compliance requirements with regards to biospecimen and imaging management
- Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts
- Experience with vendor management and the integration of vendor solutions
- Understanding of Clinical Research Sites, regional requirements, challenges and opportunities in clinical trials
- Understanding of patient needs and the patient consent process
- Familiarity with the concepts and best practices related to the management, structure, and flow of specimen data
- 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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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