0660 Biospecimen Operations Associate
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 Company’s 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 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.