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Job Title Manager, Biospecimen Lead, Consent, Biospecimen & Imaging
Self-Managed Business Role Manager, Biospecimen Lead
Support the strategic and tactical planning as well as operational management of biospecimens, which contribute to asset development. Our functional teams ensure timely availability of high-quality, accurate biological specimens, along with managing biospecimen information driven by end-to-end visibility and best-in-class logistics.
Position Summary
No direct reports (this text for hiring requisitions only)
The Manager, Biospecimen Lead, will be an independent contributor who will work closely with our Clinical Teams to develop and implement biospecimen management plans for BMS-sponsored Phase 1-4 clinical trials and externally acquired biospecimens. Members of this team will develop and execute asset and protocol-level biospecimen strategies initially under the guidance of senior colleagues 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, enabling quick decision-making and ensuring BMS's continuous competitive advantage. The individual will be responsible for supporting biospecimen management for opportunities to contribute toward optimizing work streams cross-functionally throughout the organization as it relates to biospecimens.
Position Responsibilities
Oversee and manage the complete lifecycle of biospecimens collected for clinical studies with minimal supervision.
Serve as a Core Clinical Team member responsible for providing shipping/sample movement and management, including requests, query and inventory reports, follow-up on active issues with vendors, preparing sample management-related reports, and reviewing/preparing tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc.).
Independently review clinical study protocols, providing comparisons of vendor statements of work and biospecimen-relevant sections, and offering feedback with support as needed.
Perform routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking.
Create biospecimen trackers using various tracking tools (MS Excel, Spotfire, Tableau, or Polaris, if applicable) with support.
Identify biospecimen-related risks with support from the risk library. May require support for de novo risks and mitigation strategy proposals. Support the Critical to Quality (C2Q) process with guidance, if needed.
Exercise judgment within policy and procedure boundaries. Troubleshoot routine problems and understand when it is appropriate to ask for guidance. May need assistance prioritizing BOW activities during critical deadlines.
Maintain intermediate working knowledge of compound and study-related biospecimen requirements.
Ensure completion of individual Study Transition Forms.
Degree Requirements
Scientific degree (Associates, Bachelors, Masters, or higher), Project management, or equivalent experience.
Experience Requirements
Minimum of 3-4 years of academic, biotech, healthcare, or pharmaceutical industry experience or equivalent.
Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues.
Experience desired but not limited to biospecimen life-cycle/operations, compliance, management, and vendor management.
Key Competency Requirements
Demonstrated clinical trial experience, healthcare/medical/laboratory, or equivalent.
Ability to develop skills with training for stakeholder management, including conflict and change management.
Biospecimen management experience preferred but not mandatory.
Developing knowledge of the drug discovery or developmental process.
Applies scientific and/or functional knowledge to conduct studies in assigned areas.
Ability to effectively communicate, create, and deliver presentations/information/data to knowledgeable audiences with limited supervision.
Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, act with a sense of urgency, accountability, and integrity, and have fun along the way.
Demonstrates change agility through a willingness to pivot current ways of working to new model(s).
Travel Required
N/A
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Project Management and Information Technology
Industries
Pharmaceutical Manufacturing
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