Manager, Biospecimen Management

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us. Position Summary Manager, Biospecimen Lead is an independent contributor who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-4 clinical trials. As a member of the Core Clinical Team, this role is responsible for engaging cross-functionally to develop and operationalize the specimen management plan and provide regular updates on status of samples. Critical to this role is the ability to provide solutions to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMS’s continuous competitive advantage. Responsible for supporting biospecimen management for studies with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens. Duties/Responsibilities Oversee biospecimen management in 5-12 clinical trials, with minimal supervision Develop Specimen Management Plan, highlighting risks and providing mitigations steps. Provide biospecimen input in protocol authoring to ensure operational feasibility and regulatory compliance. Track and reconcile biospecimen status using internal and external systems. Enter biospecimen requirements into a contracting system and ensure vendor documents (e.g. lab manuals, lab specs) are aligned with protocol and sample management plan. Provide regular biospecimen status updates to core clinical team (inventory, location, quality issues, timelines). Adhere to standard operating procedures and guidance documents Act as a liaison between clinical teams and vendors to coordinate biospecimen activities and resolve issues with minimal supervision. Participate in vendor audits and assist with CAPA resolutions. Maintain study documents in ‘inspection ready’ state. Participate in cross-functional projects aimed at optimizing workflows and integrating innovative technologies. Provide training and mentorship for new colleagues Maintain intermediate knowledge of therapeutic area and study related biospecimen requirements. · Qualifications Specific Knowledge, Skills, Abilities: 1. Intermediate knowledge of clinical biospecimen procedures and lifecycle including collection and tracking procedures, logistics considerations, chain of custody, issue escalation/resolution and data management highly desired. 2. Intermediate vendor experience (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc.). 3. Makes decisions that require choosing between multiple options to resolve complex problems/issues. Able to support 5-12 clinical trials, PI-IV, ranging from low to high complexity and prioritize tasks to meet company objectives. 5. Able and willing to train new colleagues 6. Effective communication skills. Able to create and deliver presentation/information/data to knowledgeable audiences, with limited supervision. 7. Demonstrates change Agility through willingness to pivot current ways to working to new model(s) 8. Demonstrates inclusion by a) ready and willing source of information for CBI colleagues b) acting as mentor to colleagues b) active listening and gathering various points of views. 9. Innovates to bring solutions that impact CBI level or higher 10. Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues. 11. 3+ years academic, biotech, healthcare or pharmaceutical industry experience or equivalent Education/Experience/ Licenses/Certifications: Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience. Travel: Travel required is minimal, 0%- 5% of time, when organization requests If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries rel