BioMarin Development Sciences collects biospecimens (human) during the execution of clinical trials through the various phases of drug development. The ability to track and manage biospecimens from collection to final disposition with essential information such as informed consent and biospecimen collection compliance is crucial for BioMarin. The Clinical Biospecimen Management group provides this support to the broader organization by ensuring that biospecimen-related activities are efficient, effective, and well-documents.
The Analyst will focus on supporting the group in a planner role with responsibility for a limited number of studies and acting under the guidance of more experienced CBM staff. Responsibility areas include serving as a point of contact for study team requests and escalating where appropriate, providing biospecimen-related input to stakeholder groups within BioMarin and maintaining the Biospecimen Management Plan (BMP).
-Primary point of contact on biospecimen management activities across all assigned studies
-Participate in Study Team meetings as a standing member
-Provide biospecimen-related input into vendor ctracts, SOWs, lab specificications, laboratory manuals, manifest
-Act as primary point of contact in resolving all biospecimen related queries
-Review biospecimen handling sections of ICF template
-Manage biospecimen tracking and reconciliation activities within the CBM systems
Experience within a laboratory and clinical trial setting's will benefit the candidate
2 years of relelvant experience working in the pharmaceutical industry (including CROs, labs and biorepositories)
Proficient with Excel/Word and Outlook is a must
BA/BS in health of life sciences or related degree