Bristol Myers Squibb
Manager,CBIBiospecimenLead(BSL)
“Manager, CBI - Biospecimen Lead (BSL) at Bristol Myers Squibb. Skills: biospecimen management, clinical trial management, cross-functional coordination, vendor management, stakeholder management. Develop and implement biospecimen management plan for BMS-sponsored Phase I-IV clinical trials.. Develop and operationalize the specimen management plan.”
Industry & Context.
Makes decisions that require choosing between multiple options to resolve complex problems/issues.
Travel required is minimal, 0%- 5% of time, when organization requests
What They're Looking For.
Must Have
4+ years academic, biotech, healthcare or pharmaceutical industry experience or equivalent, Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.
Nice to Have
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. )., Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues.
What You'll Do.
Develop and implement biospecimen management plan for BMS-sponsored Phase I-IV clinical trials.
Develop and operationalize the specimen management plan.
Provide regular updates on status of specimens.
Oversee timelines for specimen delivery.
Support biospecimen management for studies.
Optimize work streams cross functionally throughout the organization as it relates to biospecimens.
Oversee biospecimen management in 5-12 clinical trials
with minimal supervision
Develop Specimen Management Plan
highlighting operational risks and providing mitigations steps.
Provide biospecimen input in protocol authoring to ensure operational feasibility
alignment with regulations
and adherence to BMS standards.
Track and reconcile biospecimen status using internal and external systems
ensuring complete and accurate chain‑of‑custody.
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
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 and site audits
and ensure follow-through on biospecimen-related commitments.
Maintain study documents in ‘inspection ready’ state.
Participate in cross-functional projects aimed at optimizing workflows and integrating innovative technologies.
Provide onboarding support
and mentorship for new colleagues
Maintain intermediate knowledge of therapeutic area and study related biospecimen requirements.
How You'll Work.
Team & Collaboration
work closely with our Clinical Teams; engaging cross-functionally; Provide regular biospecimen status updates to core clinical team; Act as a liaison between clinical teams and vendors; Participate in cross-functional projects; Provide onboarding support, training, and mentorship for new colleagues; 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.
Communication Scope
Effective communication skills.; Able to create and deliver presentation/information/data to knowledgeable audiences, with limited supervision.
Process & Methodology
Project management or equivalent experience., Able to support 5-12 clinical trials, PI-IV, ranging from low to high complexity and prioritize tasks to meet company objectives.
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