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.