Manager II Biospecimen Lead

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:

Warsaw - PL: zł194,000 - zł235,087


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 adastaffingsupport@bms.com. 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 TAEnablement@bms.com 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