Biomarker Sample Operations Manager

Job Description

Position Title: Biomarker Sample Operations Manager

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Work Location: North Chicago, IL (60064) OR South San Francisco, CA (94080)

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Assignment Duration: 2 Years

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Work Arrangement: Hybrid

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Position Summary:

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The Precision Medicine group uses advanced methods to discover biomarkers for use in clinical trials. The Biomarker Sample Operations Manager works closely with clinical operations, project managers and laboratory managers to ensure timely and smooth collection, transfer and testing of clinical trial biomarker specimens in compliance with protocols, regulatory requirements and project timelines.

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Background & Context:

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• This role is responsible for identifying projects/tasks together with laboratory managers and works with biomarker study management teams to complete tasks. This role will drive innovation and continuous improvement activities in bio-sample collection, processing and transfers, and demonstrate ability to carry out all bio-sample operations with minimal supervision.
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Key Responsibilities:

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• Plan, organize and oversee the collection and shipping of bio-samples from investigator sites or centralized locations and subsequent delivery to assay laboratories or our organization.
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• Partner with Biomarker Program Manager and Biomarker Lead Scientist to ensure the delivery of bio-sample data in accordance with study timelines.
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• Ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases for each assigned study, reconcile sample information stored in databases.
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• Responsible for functional process and system improvements to ensure samples are collected, processed, analyzed, transported, stored and destroyed appropriately.
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• Review study-specific documents related to sample collection, handling, analysis, transport and storage as assigned.
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• Create edit checks for each sample type within assigned trials.
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• Manage relationships with laboratory vendors, provide input into trial-specific docs and assess service level commitments of labs involved in sample analysis.
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• Ensure issues are resolved or escalated in a timely manner.
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• Review lab vendor invoices to ensure work has been completed.
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• Help project managers with contract execution and vendor oversight in compliance with our organization procedures and applicable regulations.
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• May oversee laboratory vendor deliverables against the scope of work.
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• In partnership with Biomarker Program Managers, Biomarker Lead Scientists and IT, contribute to the development and implementation of a sample tracking system for assigned studies.
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• Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines.
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• Develop into a subject matter expert (SME) and resource for one or more processes in BPM.
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• Participate in process improvement initiatives or improving efficiency as needed, as well as instructions and manuals for internal training purposes.
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• Contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels mentor and develop team members as needed.
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• Balance multiple priorities in a fast-paced, team-based environment and work independently when needed.
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Qualification & Experience:

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• Master’s Degree with 3+ years project management, knowledge of oncology, including biomarkers and/or clinical trial experience.
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• Bachelor’s Degree with 4+ years of project management, knowledge of oncology, including biomarkers and/or clinical trial experience.
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• Expertise in MS Office applications including Excel, Word and PowerPoint.
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• Excellent oral and written communication skills in English.
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• Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills.
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• PMP certification a plus.
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• Clinical trial experience.
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• Scientific background and knowledge of oncology.
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• Ability to work with minor supervision.
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.