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Biospecimen Operations Associate

Bayside Solutions Novato ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Summary of Responsibilities:

  • Provide support to the BOM with SET related activities and participate in relevant cross functional meetings, as needed, throughout the life-cycle of a clinical trial
  • Prepare dashboards and trends for BOM to present at the SET
  • Review biospecimen handling sections of ICF template; provide input and guidance to Clinical Operations (CLO) on any site, country or EC specific modifications to the ICF
  • Entry of study-related data in the clinical biospecimen inventory tracking system for each supervisor-assigned study prior to First Patient In (FPI).
  • Documentation and escalation of unresolved operational issues to BOM.
  • Perform continuous tracking of clinical trial collected biospecimens.
  • Manage escalated queries generated by biorepository upon receipt of BioMarin samples, working with appropriate parties to resolve in a timely manner
  • Address biospecimen related queries from Translational Sciences/Research such as biospecimen inventory reports or clarification of the assays for which the biospecimens were collected. 
  • Participate in CBM functional process improvement projects, as needed.

Summary of Required Qualifications:

  • BA/BS in life sciences or related degree. Experience in lieu of education accepted.
  • 2 years of relevant experience working in the pharmaceutical industry (including CROs, clinical sites, labs and biorepositories).
  • 1 year of relevant technical experience working with biospecimen management, lab management, biobanking, or similar organizations.
  • Actively contributing to cross-functional team definition of goals, roles and tasks.
  • Proactively developing one’s network and work relationships outside the department.
  • Ability to create inclusive and collaborative cross-functional team and meeting environments.
  • Ability to recognize and articulate and prioritize key issues that arise based on understanding of objectives so that issues are resolved.
  • Ability to analyze and evaluate problems and seek-out and recommend possible solutions before escalation.
  • Leveraging data effectively to communicate points of view and influence outcomes.
  • Effectively track action items assigned during meetings

Summary of Desired Qualifications:

  • Understanding of end-to-end biospecimen management lifecycle, i.e., biospecimen collection, processing, storage and shipping.
  • Understanding informed consent and its impact on biospecimen management.
  • Solid understanding of GxP principals and how they impact biospecimen operational and vendor management activities, and what appropriate steps and path need to be taken to escalate.
  • Understanding of study protocol objectives and methodology.

 

Bayside Solutions

Address

Novato, CA
94949 USA