Biomarker Operations Project Manager

South San Francisco, CA 94080 | Contract

Post Date: 06/22/2018 Job ID: 4414 Industry: Drug Development - Med/Clinical Affairs

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties: **Please note that this is for a Biomarker Operations Project Manager**
  • Main Responsibilities and Accountabilities: 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 biomarkersamples (including companion diagnostic samples) * (collection, processing, analysis, data delivery process and final sampledisposition)
  • Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to executebiomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internaland external stakeholders
  • Develops and maintains effective working relationships with SMT members, with particularfocus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarkervendors, where applicable
  • Builds and maintains effective and efficient high performing biomarker sample* analysis & data delivery
  • Supports relevantstakeholders 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 anddiagnostics/CDx managers; ensuring appropriate cross-functional input is incorporated into the scope of work
  • Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consentat study level

 

 

Skills:

  • Skills & Knowledge: Experience
  •  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. Further qualification, e.g.PhD and/or project management certification is desirable.
  • 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, orpharmaceutical/biotechnology R&D environment
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