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Clinical Biospecimen Operations Manager

Natera

$111,900 - $139,900
Apr 15, 2025
Remote, US
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The company is looking to solve the problem of efficiently managing clinical trial samples and data in oncology research studies.

Requirements

  • Familiarity with biospecimen management, sample processing, and biobanking best practices
  • Experience with clinical EDC systems
  • Familiarity with the organization and structure of the Trial Master File (TMF)
  • Competency in SOPs, ICH-GCP, FDA Regulations
  • Proficiency in MS Word, Excel and PowerPoint
  • Experience with electronic Trial Master File (eTMF)

Responsibilities

  • Maintain oversight of all study sample operational activities
  • Work with Data Management to develop and maintain dashboards and KPIs
  • Meticulously track clinical trial samples from sample receipt to result reporting
  • Utilize operational and project management skills to anticipate, investigate and resolve issues
  • Review and provide input to clinical study protocol for sample collection requirements
  • Oversee clinical trial supplies related to biospecimen collection, processing, shipment, and storage
  • Monitor studies to identify protocol deviations or data discrepancies

Other

  • BA/BS degree in life sciences, related field, or equivalent
  • Minimum of 5 years of experience working on clinical studies
  • Demonstrated ability to work independently
  • Outgoing and confident demeanor
  • Demonstrated analytical skills and ability to identify problems and propose solutions
  • Detail oriented, with solid organization and time management skills
  • Must maintain a current status on Natera training requirement including General Policies and Procedure Compliance and security training
  • Must pass post offer criminal background check
  • Must provide records of current training or complete training relating to HIPAA/PHI privacy, human subject’s protection, and GCP