Role at a glance
- Salary
- Not Disclosed
- Location
- Warsaw-WeWork-PL
- Employment
- Full-time
- Experience
- 3+ years academic, biotech, healthcare or pharmaceutical industry experience or equivalent
- Education
- Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.
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Role Summary
The Manager, Biospecimen Lead independently supports biospecimen management for BMS-sponsored Phase 1–4 clinical trials as part of Core Clinical Teams. The role develops and operationalizes specimen management plans and coordinates with clinical teams and vendors on sample status, timelines, and issues.
What You'll Do
- Oversee biospecimen management across 5–12 clinical trials and develop specimen management plans that identify risks and mitigation steps.
- Provide biospecimen input during protocol authoring to support operational feasibility and regulatory compliance.
- Track and reconcile biospecimen status, and provide regular updates on sample inventory, location, quality issues, and timelines.
- Coordinate biospecimen activities with vendors, resolve issues, and ensure vendor documents align with protocols and specimen management...
- Participate in vendor audits, assist with CAPA resolutions, and maintain study documents in inspection-ready condition.
- Contribute to cross-functional workflow optimization and technology integration projects, and provide training and mentorship to new...
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Requires intermediate vendor experience; clinical-trial prioritization and problem-solving; effective communication and presentation skills; willingness to train colleagues; change agility, inclusion, and innovation; and basic knowledge of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues.
Required
- Intermediate vendor experience, such as with Central Labs, Bioanalytical, Biomarker, CROs, or Biospecimen Storage Vendors.
- Ability to choose between multiple options to resolve complex problems or issues.
- Ability to support 5–12 clinical trials, PI–IV, ranging from low to high complexity, and prioritize tasks to meet company objectives.
- Ability and willingness to train new colleagues.
- Effective communication skills, including creating and delivering presentations, information, or data to knowledgeable audiences with...
- Change agility, including willingness to pivot to new ways of working.
- Inclusion through being a source of information for CBI colleagues, mentoring colleagues, active listening, and gathering different...
- Innovation that brings solutions with CBI-level impact or higher.
Preferred
- Highly desired: intermediate knowledge of clinical biospecimen procedures and lifecycle, including collection and tracking procedures,...
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.
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 and 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:
- 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.
- Intermediate 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.
- Able to support 5-12 clinical trials, PI-IV, ranging from low to high complexity and prioritize tasks to meet company objectives.
- Able and willing to train new colleagues
- Effective communication skills. Able to create and deliver presentation/information/data to knowledgeable audiences, with limited supervision.
- Demonstrates change Agility through willingness to pivot current ways to working to new model(s)
- 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.
- undefined
- Innovates to bring solutions that impact CBI level or higher
- Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues.
- 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
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 compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.
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.
R1606674 : Manager II 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.