Role at a glance
- Job function
-
Healthcare Other
- Salary
- Not yet verified Check the description for pay details; an amount or pay period has not been verified.
- Location
- Princeton, New Jersey, United States
- Employment
- Full-time
- Experience
- Senior Level Minimum of 5-6 years academic, biotech, healthcare or pharmaceutical industry experience.
- Education
- Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.
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Role Summary
The Senior Manager, Biospecimen Lead works with clinical teams to develop and implement biospecimen management plans and strategies for BMS-sponsored Phase 1–4 trials and externally acquired biospecimens. The role coordinates specimen operations and works across the organization and with vendors to support delivery of specimen data and management of study-related biospecimen requirements.
What You'll Do
- Oversee biospecimen lifecycle activities, including collection, storage, use and final disposition, and create specimen management plans...
- Coordinate shipping and sample movement, inventory and tracking reports, vendor follow-up, and specimen-related documentation.
- Review study protocols against vendor statements of work and provide feedback on biospecimen-related sections.
- Manage vendor activities and specimen tracking using available inventory files and tracking tools.
- Identify and manage biospecimen-related risks and issues, support Critical to Quality processes, and propose mitigations to stakeholders.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Scientific degree, project management or equivalent experience; demonstrated clinical-trial experience in healthcare, medical, laboratory or equivalent settings; knowledge of drug discovery or development; vendor experience; understanding of GCP, GLP, CLIA, data management, risk management and regulatory issues; project and stakeholder management, communication, conflict and change management, and protocol-related skills.
Required
- Deep knowledge of clinical biospecimen procedures and lifecycle, including collection and tracking procedures, logistics considerations,...
- Experience preferred but not limited to: biospecimen life-cycle/operations, biospecimen result and data flows, compliance, management,...
Preferred
- Deep knowledge of clinical biospecimen procedures and lifecycle, including collection and tracking procedures, logistics considerations,...
- Experience preferred but not limited to: biospecimen life-cycle/operations, biospecimen result and data flows, compliance, management,...
Original job description
Content provided by the employer
Original job description
Content provided by the employer
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
Senior 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 and externally acquired biospecimens. Will develop and execute asset and protocol-level biospecimen strategies and work across the organization and with BMS’s partners to implement and project manage efforts to execute these strategies. Critical to this role is the ability to provide innovative 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 assets with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens
Duties/Responsibilities
- Oversee and manage the complete lifecycle of biospecimens (collection, storage, use, and final disposition) for clinical studies with minimal to no supervision.
- Core Clinical Team member responsible for creating the Specimen Management Plan and facilitates discussions to operationalize strategy.
- Providing Shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc.).
- Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and provide feedback.
- Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking with minimal Data Integration with enrollment and vendor specimen inventory.
- Able to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable)) with minimal support.
- Able to identify biospecimen related risks with support from risk library as well as de novo. Manage Critical to Quality (C2Q) processes with clinical teams. Can identify and resolve vendor related issues in addition to vendor management responsibilities.
- Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and provide mitigation proposals to stakeholders. Prioritize BOW activities during critical deadlines with little or no supervision.
- Maintain advanced working knowledge of compound and study related biospecimen requirements. Seeks knowledge beyond own area of specialty.
Qualifications
Education/Experience/ Licenses/Certifications:
- Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.
Specific Knowledge, Skills, Abilities:
- Deep 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.
- Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent. Has developed Knowledge of the drug discovery or development process.
- Vendor experience (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc.).
- Makes decisions that require choosing between multiple options to resolve complex problems/issues.
- Ability to display skills for stakeholder management including conflict and change management.
- Actively participates and demonstrates the ability to independently manage projects and initiatives in addition to assigned BOW.
- Serves as SME/coach for junior staff to autonomously support trials.
- Plans, directs, and executes functional area processes for protocol related activities.
- Key participant in cross functional team meetings. Effectively communicate, create and deliver presentation/information/data to knowledgeable audiences, without supervision.
- Demonstrates "Change Agility" by accepting new tasks and effectively working in multiple different operating models.
- 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.
- Identifies issues and suggests solutions.
- Acts as CBI and GDO "ambassador" by exhibiting general knowledge of other GDO departments and responsibilities and willingly educates stakeholders.
- Minimum of 5-6 years academic, biotech, healthcare or pharmaceutical industry experience.
- Solid understanding of clinical and biomedical research including aspects such as: GCP, GLP, CLIA, data management, risk management, and regulatory issues.
- Experience preferred but not limited to: biospecimen life-cycle/operations, biospecimen result and data flows, compliance, management, and vendor management.
Travel: Travel required is minimal, 0%- 5% of time, when required per study team request to support site training or vendor due diligence activities
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: 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 this posting is missing required information required by local law or incorrect, contact BMS at [email protected]with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1607669 : Senior Manager Biospecimen Lead
About the company
Bristol Myers Squibb
Large Enterprise
Bristol Myers Squibb is a global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a focus on oncology, immunology, and cardiovascular health, the company leverages advanced science and technology to create transformative therapies that address critical unmet medical needs. Operating in more than 70 countries, Bristol Myers Squibb emphasizes collaborative efforts and strong partnerships in research and development to drive advancements in healthcare and improve patient outcomes worldwide.