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Biomarker Operations Manager

Yoh Staffing Solutions
South San Francisco, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

YOH is seeking a Biomarker Operations Manager for our Clinical Stage Pharmaceutical client in San Francisco, CA. This candidate will be responsible for the biomarker operations and bio-specimen management to support the company’s clinical trials.

This role entails working with Biomarker Scientists, Clinical Operations, Legal and other cross-functional team representatives to ensure successful completion of all biomarker activities/project deliverables. The position will also contribute to strategy and logistics of the biomarker plan, as well as oversee third-party vendors that provide biomarker testing.

Pay Rate: DOE
Hours: M-F first shift, with flexible hours
Industry: Pharmaceutical
Location: South San Francisco – this position is a remote opportunity, with occasional onsite needs
Type: Fulltime

Responsibilities

  • Plans, coordinates and oversees biomarker sample management and testing
  • Oversees sample collection, QC, shipment, receipt, cataloging, compliance, storage, and maintenance of bio-sample inventories
  • Responsible for biomarker vendor management including oversight of scopes of work, timelines, deliverables, budgets, invoices and vendor communication
  • Coordinates sample analysis at CROs including sample mobilization, creating sample manifests, sample shipping, analysis of bio-specimens, data delivery
  • Establishes biomarker sample analysis and data delivery milestones and ensures accurate tracking and reporting of biomarker data metrics
  • Contributes to vendor selection and may be asked to train CROs, vendors, investigators and study coordinators on study requirements
  • Partners with team in lab set up, providing lab manual processing instructions, design of lab kits, shipping conditions for biomarker samples, and sample tracking
  • Responsible for authoring documentation related to biomarker studies (eg SOWs, lab manuals, clinical trial protocols)
  • Engages in team meetings and collaborates with staff from Biology, Clinical Operations, Clinical Data Management, Biostatistics, Regulatory/QA, and Pharmacology
  • Collaborates closely with biomarker scientists and clinical trial managers to execute biomarker operational strategies, serving as a single point of contact for biomarker operations with internal team members and external vendors

Qualifications

  • Bachelor’s degree or higher required in relevant scientific or healthcare discipline. 3+ years of experience in biomarker operations and bio-specimen management is required
  • Strong CRO relationship management skills including managing budgets and timelines
  • Experienced in overseeing the operational aspects of clinical studies relating to clinical biomarkers
  • Proficient in managing all aspects of biomarker sample lifecycle
  • Experienced in contributing to biomarker-related trial documentation e.g. lab manuals, ICFs, protocols
  • In depth understanding of biomarker techniques: IHC, flow cytometry, transcriptomic and genomic platforms is preferred
  • Background in cancer biology enabling thorough understanding of biomarker study goals and rational is preferred
  • Working knowledge of use of Next Generation Sequencing in clinical studies a plus • Project management skills including planning, organizational, record keeping and time management
  • Strong MS Excel skills. Working knowledge of sample tracking systems
  • Detail oriented with the ability to work independently and manage multiple competing priorities
  • Flexibility to adapt to changing program needs in real time
  • Professional inter-personal skills with strong verbal and written communication abilities
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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
Company Description
Investment Management Company

Yoh Staffing Solutions

Investment Management Company

Address

South San Francisco, CA
USA

Industry

Business

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