Biomarker Sample Operations Manager III - Biosample Logistics and Vendor Oversight
- Compensation
- Not disclosed
- Location
- United States, Illinois, North Chicago
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Contract
- Experience
- 2+ years
- Category
- Operations
- Posted
Skills
Must have
- Master’s degree with 3+ years of project management experience, or a bachelor’s degree with 4+ years of project management experience, with knowledge of oncology, including biomarkers, and/or clinical
- Clinical trial experience, a scientific background, and knowledge of oncology.
- Strong organization, attention to detail, and time management, with the ability to adapt to changing priorities; excellent analytical and interpersonal skills.
- Expertise in Microsoft Office applications, including Excel, Word, and PowerPoint.
- Excellent oral and written communication skills in English.
- Ability to work with minimal supervision.
- PMP certification is a plus.
Full description
**Biomarker Sample Operations Manager III - Biosample Logistics and Vendor OversightLocation: Hybrid in Lake County, IL (preferred), or South San Francisco, CALength of Assignment: 2 yearsPay Rate: $38-41/hr (medical benefits available at a cost)Openings: 2
Job Description:
The Precision Medicine group uses advanced methods to discover biomarkers for clinical trials. The Biomarker Sample Operations Manager III partners with Clinical Operations, project managers, and laboratory managers to ensure timely collection, transfer, and testing of clinical trial biomarker specimens in compliance with protocols, regulatory requirements, and project timelines. The role identifies projects and tasks with laboratory managers, works with biomarker study management teams to complete them, and drives innovation and continuous improvement in biosample collection, processing, and transfer with minimal supervision.
- Plan, organize, and oversee biosample collection and shipping from investigator sites or centralized locations to assay laboratories or company sites. Partner with Biomarker Program Managers and Biomarker Lead Scientists to deliver biosample data according to study timelines.
- Ensure timely shipments to vendors and storage sites, transfer data to the correct study databases, and reconcile sample information stored in databases.
- Lead functional process and system improvements to ensure samples are appropriately collected, processed, analyzed, transported, stored, and destroyed.
- Review study-specific documents for sample collection, handling, analysis, transport, and storage. Create edit checks for each sample type within assigned trials.
- Manage laboratory vendor relationships, contribute to trial-specific documents, assess service-level commitments, and resolve or escalate issues promptly. Review vendor invoices to confirm completion of work.
- Support project managers with contract execution and vendor oversight in compliance with company procedures and applicable regulations. May oversee vendor deliverables against the scope of work.
- Partner with Biomarker Program Managers, Biomarker Lead Scientists, and IT to develop and implement sample tracking systems for assigned studies.
- Adhere to ICH/GCP, biostorage procedures, biosample management best practices, and ethical guidelines.
- Develop subject matter expertise in one or more BPM processes. Support process improvements, efficiency initiatives, and instructions and manuals for internal training.
- Promote mutual respect, innovation, and accountability. Mentor and develop team members as needed, balance multiple priorities, and work independently when required.
Qualifications:
- Master’s degree with 3+ years of project management experience, or a bachelor’s degree with 4+ years of project management experience, with knowledge of oncology, including biomarkers, and/or clinical trial experience.