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Biomarker Operations Project Manager
Ref No.: 18-04094
Location: South San Francisco, California
Duties:
  • Provides biomarker operational expertise and guidance to global Study Management Teams (SMTs)
  • Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples) (collection, processing, analysis, data delivery process and final sample disposition)
  • Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.
  • Develops and maintains effective working relationships with SMT members, with a particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors, where applicable
  • Builds and maintains effective and efficient high performing biomarker sample* analysis & data delivery
  • Supports relevant stakeholders in their accountabilities, responsibilities, and deliverables to drive decisions on timelines
  • Responsible for the identification and selection of biomarker vendors in collaboration with the BOPL, biomarker scientist, GPPS and diagnostics/CDx managers; ensuring appropriate cross-functional input is incorporated into the scope of work
  • Ensure the collection, delivery, and analysis of biosamples under the highest standards of quality, ethics, and informed consent at the study level
Skills:
  • Extensive clinical development experience with evidence of working in teams running clinical studies
  • Pharmaceutical industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
  • Project management skills
  • Critical reasoning skills including the identification and resolution of complex problems
  • Detail oriented with the ability to work independently and manage multiple competing priorities
  • Planning, organizational and time management skills
  • Highly flexible in a fast pace global matrix environment
  • Professional interpersonal skills, excellent oral/written communication, and influencing skills
  • Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Creates team culture and promotes team spirit.
  • Global Vendor Management experience preferred
  • Good knowledge of ICH GCP Competencies
  • Strategic Agility • Inspiring and Influencing • Teamwork and Collaboration • Communication • Technical and Business Expertise • Achieving Results
Education:
  • Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required.
  • Ph.D. and/or project management certification is desirable.
  • 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment