Biospecimen Operations Manager

Location:  San Rafael, California Category: Research Employment Category: Fulltime-Temporary

Description

**PLEASE NOTE: THIS REQUISITION IS FOR 2 POSITIONS**

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

DUTIES:

  • Open to Hybrid - or remote for right candidate 
  • Provide input during vendor selection process for new or former central and specialty labs considered for BioMarin 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 BioMarin’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.
    • 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 BioMarin’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 BioMarin, 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.
    • 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).
SKILLS:
  • 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.
EDUCATION:
  • 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.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.