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Biomarker Operations and Sample Management Specialist

Bayside Solutions • Fremont, CA 94537 • Posted 1 day ago via LinkedIn

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Hybrid • Full-time • $83,200-$124,800/yr • Contract • Mid Level

Job Highlights

Using AI ⚡ to summarize the original job post

As a Biomarker Operations and Sample Management Specialist within the Translational Medicine function, you will provide biomarker operational expertise, define the scope of work, and maintain strong working relationships with cross-functional teams for phase three clinical trials. This role involves operationalizing the CDx strategy, collaborating with biomarker scientists and clinical operations, and managing CROs to ensure timely delivery with high-quality standards.

Responsibilities

  • Operationalize the CDx strategy to support early and late-stage development of portfolio assets.
  • Effectively collaborate with biomarker scientists and clinical operations to ensure successful collection and CDx testing of clinical trial samples.
  • Collaborate with diagnostic partners and internal cross-functional team members to ensure successful management of CDx samples.
  • Work closely with the Clinical operations group for central lab setup, including kit design, sample processing instructions, and logistics.
  • Work closely with biomarker scientists to oversee the development of the scope of work, budgets, and timelines by CROs.
  • Assist in sample reconciliation between central labs and biomarker vendors/CROs.
  • Perform day-to-day operational management of CROs to ensure timely delivery with a high-quality standard.
  • Provide sample and assay status updates to biomarker and diagnostic sub-teams.

Qualifications

Required

  • Life sciences degree (BS or MS) in a scientific, medical, healthcare, or related discipline
  • 3+ years of related professional experience in a clinical research setting and clinical/diagnostic laboratory
  • Prior experience in clinical biomarker operation and/or sample management in phase three clinical trials is highly desirable.
  • Excellent scientific and business communication, strong interpersonal, collaboration, and planning skills
  • Able to think critically and creatively and work independently to determine appropriate resources to resolve problems.
  • Able to multi-task and thrive in a fast-paced, innovative environment.
  • A great teammate who listens effectively and invites responses and discussion
  • Proficiency with Microsoft Excel and PowerPoint is desirable.
  • Experience in using project management tools is a plus.

Preferred

  • Clinical research
  • Biomarker operations
  • Sample management
  • Clinical trial
  • Excel
  • PowerPoint

About Bayside Solutions

Bayside Solutions is an industry-leading provider of staff augmentation and consulting services based in San Ramon, CA. They specialize in recruiting IT & telecom, engineering, and scientific staff in the Bay Area, offering intelligent staffing solutions for businesses and careers to grow. Their services include IT staffing solutions, managed services, clinical & scientific staffing, and creative & marketing staffing.

Full Job Description

Biomarker Operations and Sample Management Specialist

W2 Contract

Salary Range: $83,200 - $124,800 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

As a Biomarker Operations and Sample Management Specialist within the Translational Medicine function, you will play a key role by providing biomarker operational expertise, defining the scope of work, and maintaining strong working relationships with cross-functional teams for phase three clinical trials.


Duties and Responsibilities:

  • Operationalize the CDx strategy to support early and late-stage development of portfolio assets.
  • Effectively collaborate with biomarker scientists and clinical operations to ensure successful collection and CDx testing of clinical trial samples.
  • Collaborate with diagnostic partners and internal cross-functional team members to ensure successful management of CDx samples.
  • Work closely with the Clinical operations group for central lab setup, including kit design, sample processing instructions, and logistics.
  • Work closely with biomarker scientists to oversee the development of the scope of work, budgets, and timelines by CROs.
  • Assist in sample reconciliation between central labs and biomarker vendors/CROs.
  • Perform day-to-day operational management of CROs to ensure timely delivery with a high-quality standard.
  • Provide sample and assay status updates to biomarker and diagnostic sub-teams.


Requirements and Qualifications:

  • Life sciences degree (BS or MS) in a scientific, medical, healthcare, or related discipline
  • 3+ years of related professional experience in a clinical research setting and clinical/diagnostic laboratory
  • Prior experience in clinical biomarker operation and/or sample management in phase three clinical trials is highly desirable.
  • Excellent scientific and business communication, strong interpersonal, collaboration, and planning skills
  • Able to think critically and creatively and work independently to determine appropriate resources to resolve problems.
  • Able to multi-task and thrive in a fast-paced, innovative environment.
  • A great teammate who listens effectively and invites responses and discussion
  • Proficiency with Microsoft Excel and PowerPoint is desirable.
  • Experience in using project management tools is a plus.


Desired Skills and Experience

Clinical research, biomarker operations, sample management, clinical trial, Excel, PowerPoint



Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.


Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.

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