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Biomarker Operations Project Manager IV

Job Description

Biomarker Operations Project Manager / Biomarker Operations Project Manager IV
Req
ROCGJP00012726
Type: W2 contractor
Ideal Assignment Dates: 08/26/2021 to 08/30/2024
**Some travel may be required
Direct reports: None
Position Purpose:
  • Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs)
  • Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies through all phases (phase 1b-IV) supported by PD and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
Main Responsibilities and Accountabilities:
  • Provides biomarker operational expertise and guidance to global Study Management Teams (SMTs)
  • Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans,
  • Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
  • Delivers the operational elements of the biomarker management plan
  • Identifies areas of best practice and process improvements
  • Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
  • Ensures study adherence to ICH/GCP and SOPs
Qualifications:
  • 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, or pharmaceutical/biotechnology R&D environment
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

    Job Requirements

     

    Job Snapshot

    Location US-CA-South San Francisco
    Employment Type Contractor
    Pay Type Hour
    Pay Rate $0.00 - $99.28 /Hour
    Store Type Energy, Oil & Gas, Clinical & Scientific
    Apply

    Company Overview

    Ascent

    The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

    Contact Information

    US-CA-South San Francisco
    Afreen Naaz
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    Snapshot
    Ascent
    Company:
    US-CA-South San Francisco
    Location:
    Contractor
    Employment Type:
    Hour
    Pay Type:
    $0.00 - $99.28 /Hour
    Pay Rate:
    Energy, Oil & Gas, Clinical & Scientific
    Store Type:

    Job Description

    Biomarker Operations Project Manager / Biomarker Operations Project Manager IV
    Req
    ROCGJP00012726
    Type: W2 contractor
    Ideal Assignment Dates: 08/26/2021 to 08/30/2024
    **Some travel may be required
    Direct reports: None
    Position Purpose:
    • Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs)
    • Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies through all phases (phase 1b-IV) supported by PD and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
    Main Responsibilities and Accountabilities:
    • Provides biomarker operational expertise and guidance to global Study Management Teams (SMTs)
    • Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans,
    • Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
    • Delivers the operational elements of the biomarker management plan
    • Identifies areas of best practice and process improvements
    • Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
    • Ensures study adherence to ICH/GCP and SOPs
    Qualifications:
    • 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, or pharmaceutical/biotechnology R&D environment
    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

      Job Requirements

       
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      Biomarker Operations Project Manager IV Apply now