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Biomarker Operations Specialist

Hertfordshire   •  Negotiable  •  Contract/Temporary, Full time



  • Drives alignment of study and project level strategies within the overarching therapeutic area strategy for biosamples, through close partnership with the Biosample Therapeutic Area Leaders (BTALs), service providers (including lab vendors) and DTA stakeholders

  • Is responsible for the delivery and implementation of the biosample strategy within multiple clinical programmes in accordance with the requirements of quality, ethical and regulatory standards including ICH/GCP/GLP

  • Ensures project level consistency for biosampling across studies and is the primary point of contact within Biosample Operations for project, clinical and study teams

  • Delivers expert input on strategic direction and operational considerations for Biomarker sampling to project and study teams

  • Leads or contributes to innovation and continuous improvement activities in the area of biosample collection, processing and data delivery



Primary Responsibilities and Accountabilities:



  • To provide operational expertise to ensure the successful implementation of the biosample strategy for a given molecule or clinical programme



  • To ensure the appropriate level of sample quality, defining corrective actions if necessary, and acting as a point of escalation for issues at the study and project levels



  • To implement the biosample sourcing strategy within given projects through partnership with the BTAL and other key stakeholders involved in project and study delivery

  • To be accountable for project level oversight (from feasibility to study close) of laboratories/vendors and associated costs involved in biosampling activities and analyses. Provides input to the laboratory selection process to ensure appropriate vendor selection where applicable

  • Leads cross-functional operations team meetings as required to ensure optimal delivery of project biosampling objectives

  • To actively promote knowledge sharing within Clinical Operations and across studies within a project by partnering with stakeholders.



Education / Qualifications:





      • Life sciences degree or equivalent qualification




Experience, Skills, Knowledge



  • Significant experience implementing clinical trials - required

  • Extensive experience in leading and managing biosample operational activities on a range of logistically complex multi-centre clinical studies, - preferred

  • Demonstrated knowledge of ICH GCP

  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples



  • Demonstrated leadership skills



  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse matrix environment

  • Proven ability to influence effectively and confidently within a matrix environment

  • Knowledge of legal and regulatory environment related to human specimen collection, analysis and retention



You must be eligible to work in the UK. Learn more

  • Agency: Key People
  • Reference: mc25117
  • Posted: 25th September 2020
  • Expires: 23rd October 2020

Key People

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