Biospecimen Operations Lead for Clinical Trials

Bristol-Myers Squibb Co; Warszawa; On-site; PLN 194,000 - 235,000; Full time

Job summary

Bristol Myers Squibb is seeking a Manager II Biospecimen Lead to partner with clinical teams in designing and implementing a biospecimen management plan for phase 1-4 trials. You will oversee specimen workflows, timelines, and data delivery to enable timely decision-making and maintain competitive advantage.

The role requires coordinating with vendors, sites, and cross-functional teams, developing risk mitigations, and ensuring regulatory readiness. Travel is minimal.

Qualifications

• 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.
• 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.
• Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.

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.

Skills

Biospecimen procedures

Vendor experience

Clinical trials coordination

Communication skills

Training others

Regulatory knowledge

Education

Scientific degree

Project management experience

Job description

Bristol Myers Squibb is seeking a Manager II Biospecimen Lead to partner with clinical teams in designing and implementing a biospecimen management plan for phase 1-4 trials. You will oversee specimen workflows, timelines, and data delivery to enable timely decision-making and maintain competitive advantage.

The role requires coordinating with vendors, sites, and cross-functional teams, developing risk mitigations, and ensuring regulatory readiness. Travel is minimal.