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Clinical Biomarker Operations Associate

Cambridge, MA

Posted: 11/20/2019 Employment Type: Contract Job Category: Clinical: Clinical Operations and Development Job Number: 2479

Job Description

This role is primarily focused on leading clinical biomarker activities and coordination between our client’ s clinical operations and data sciences groups as well as external vendors to ensure timely delivery of biomarker results for clinical programs.

Principal Duties and Responsibilities:
  • Biomarker sample logistics
    • Track the collection and shipment of biomarker clinical samples from the clinical site to biobanks or processing lab; working closely with CRO/ operations group to ensure all samples are collected and shipped according to schedule.
    • Coordinate shipments of samples to 3rd party laboratories for testing; tracking and confirming samples are received at vendors
    • Work closely with clinical operations/CROs and/or clinical sites to resolve sample related issues in a timely manner
  • Biomarker vendor and data management
    • Clear understanding of clinical biomarker plan, to ensure documentation is aligned with the project team’ s goals (laboratory manuals, informed consents, analytical plans, and SOWs).
    • Developing and updating data transfer specifications by gathering input from biomarker leads, data management and data scientists to get consistent data transferred to our internal systems
    • QC and monitoring of testing to ensure data provided by vendors meet requirements.
    • Updating and maintaining internal Biomarker LIMS and database with data received from vendors or generated internally
  • Primary manager of the biomarker group biobank
    • Responsible for receiving and registering into the biomarker LIMS system, clinical samples which will be processed in-house.
    • Coordinating shipments of clinical samples to off-site biobank for long-term storage upon completion of testing.
    • Sourcing commercial samples (both retrospective and prospective collections) from external biobanks/vendors to support projects

Requirements / Qualifications:
  • BS/MS in Biological sciences with minimum 2 years experience, 5 years preferred, leading biomarker operations for clinical studies.
  • Prior experience with prospective biomarker testing and experience in pivotal clinical studies involving a diagnostic development is highly desirable.
  • Outstanding organizational skills and capacity to prioritize multiple tasks
  • Excellent people skills with ability to efficiently interface with multiple groups including clinical operations, data sciences and external CROs.

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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