- 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.
- 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).
- Set-up and maintain all planned biospecimen-relevant information including details for each biospecimen collected.
- Maintain relevant documentation in clinical biospecimen inventory tracking system.
- Perform continuous tracking of clinical trial collected biospecimens.
- Support BOM with biospecimen tracking and reconciliation activities for all assigned studies in the Companys in-house clinical biospecimen inventory tracking IT system.
- Fulfill analysis requests for use of samples.
- Maintain the scope of work between the external biorepository and the Company.
- Manage escalated queries generated by biorepository upon receipt of the Companys samples.
- Escalate queries that cannot be resolved within an agreeable timeframe to the BOM.
- Address biospecimen related queries from Translational Sciences/Research Work with relevant parties to track biospecimen specific information to assist researchers with selecting of biospecimens for testing.
- Participate in CBM functional process improvement projects, as needed.
- 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.
- 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.