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Clinical Biomarker Operations Associate

Company: Apex Systems, Inc
Location: Cambridge
Posted on: January 17, 2020

Job Description:

Job Description Job #: 1025048Clinical Biomarker Operations Associate 1025048 Job Scope & Purpose: Our Cambridge based client is looking for an outgoing, Clinical Biomarker Operations Associate with excellent people skills to join their team. This is a dynamic, exciting opportunity, involving biomarker sample logistics, vendor and data management, and management of the biomarker group biobank. If an interactive, cross-functional role sounds like your next career move, please apply! Primary Job 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 groups 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 company programs 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 meets companiesrequirements.
  • 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 the 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 company projects Primary Job Requirements:
    • BS/MS in Biological Sciences with a minimum of 2 years' experience, 5 years preferred, leading biomarker operations for clinical studies.
    • Prior experience with prospective biomarker testing and experience in pivotal clinical studies involved in diagnostic development is highly desirable.
    • Outstanding organizational skills and capacity to prioritize multiple tasks
    • Excellent people skills with the ability to efficiently interface with multiple groups including clinical operations, data sciences and external CROs. About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT--- Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. dhagenbuch@stratacuity.com Code: DiscDevt EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178. - provided by Dice

Keywords: Apex Systems, Inc, Boston , Clinical Biomarker Operations Associate, IT / Software / Systems , Cambridge, Massachusetts

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