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Biospecimen Operations Manager

San Rafael, CA 94903

Posted: 11/17/2022 Employment Type: Contract Job Category: Scientific Job Number: 507808-1 Is job remote?: Yes Country: United States

Job Description

  • Provide input during vendor selection process for new or former central and specialty labs considered for this company's clinical trials.
  • Participate in the central and specialty laboratories sourcing process that includes identification, evaluation, and selection of vendors that would be the best fit for each study’s needs and documenting recommendations and decisions.
  • Establish various documents and plans to ensure the company's  and vendor’s expectations are aligned so vendor performance and quality metrics are developed, agreed and implemented.
  • Participate in and/or lead vendor conference calls on relevant topics.
  • Act as SET point of contact for vendor management throughout life of a protocol.
  • Report relevant vendor questions/issues to SETs and other cross-functional teams as needed.
  • Perform the initial vendor invoice review and payment from the internal accounting system and provide input to CLO for their final approval of pending invoices.
  • Maintain trackers of biospecimen-related information.
    • On vendor activity and biospecimen sample handling.
    • To consult on decisions regarding biospecimen collection, kit design, shipping schedule, and data deliverables.
    • In the evaluation of site performance for protocol-defined lab procedures.
    • On ICF wording of biospecimen-related sections to ensure defined standards are met.
    • Entry of study-related data in the clinical biospecimen inventory tracking system for each supervisor-assigned study prior to First Patient In (FPI).
      • Set-up and maintain all planned biospecimen-relevant information including details for each biospecimen collected.
      • Leverage input for more accurate price alignment between central and specialty lab cost proposals with actual biospecimen and testing needs.
      • Manage biospecimen tracking and reconciliation activities for all assigned studies in the company's in-house clinical biospecimen inventory tracking IT system.
      • Act as the first point of contact for biospecimen requests, e.g., Analysis Request (AR), fulfillments.
      • Review shipping requirements and ensure shipping manifest aligns for all labs.
      • Develop a scope of work between the external biorepository and our internal company, which will be captured in the biorepository operation documentation.  
      • Facilitate inquiries related to the appropriateness or integrity of biospecimens, work with CBM Steward on disposal requests as appropriate.
      • Participate in CBM functional process improvement projects, as needed.
  • Manage existing central and specialty laboratories to address any operational questions/issues that arise and resolve or triage to the appropriate individual or cross-functional group.
  • Participate in SET and other cross functional meetings as a standing member throughout the life-cycle of a clinical trial to providing input:
  • Documentation and escalation of unresolved operational issues to department senior management and SET Lead.
  • Collaborate with CBM and data management teams, along with vendors for appropriate documentation and plans of biospecimen inventory and testing results.
  • Perform continuous tracking of clinical trial collected biospecimens.
  • Consult on internal and external training documentation on biospecimen management procedures and proper completion of biospecimen transfer documents.
Requirements:
  • BA/BS in life sciences or related degree. Experience in lieu of education accepted.
  • 6 years of relevant experience working in the pharmaceutical industry (including CROs, clinical sites, labs and biorepositories).
  • 4 years of relevant technical experience working with biospecimen management, lab management, biobanking, or similar organizations.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About San Rafael, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Rafael, California area! Nestled in Marin County, San Rafael offers a perfect blend of picturesque landscapes, cultural attractions such as the Marin Veterans' Memorial Auditorium and the Marin History Museum, and a thriving culinary scene with diverse eateries like Sol Food and Terrapin Crossroads. This charming city also boasts easy access to outdoor adventures at China Camp State Park and opportunities to appreciate local art at the Falkirk Cultural Center. Join us in San Rafael, where career growth meets undeniable charm – apply now and discover your next career move in this dynamic region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.