Regeneron
SrSampleManagementSpecialist
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr Sample Management Specialist at Regeneron. Skills: Sample management, Biobanking operations, Data management. Interpret study protocols. Execute study reference file creation”
Industry & Context.
Troubleshoot issues; Data discrepancy resolution; Analyze discrepancies; Interpret discrepancies
Safety in laboratory
What They're Looking For.
Must Have
Bachelor's degree with 6 years of relevant post-degree laboratory experience, Master's degree with 4 years of relevant post-degree laboratory experience
What You'll Do.
Interpret study protocols
Execute study reference file creation
Manage biosample operations
Manage reconciliation and data cleaning
Collaborate with Data Management
Draft and review Data Transfer Specifications
Liaise with Global Clinical Development
Liaise with Central Laboratories
Provide input for biosample operations
Provide planning for biosample operations
Provide integration of biosample operations
Create sample collection instructions
Review sample collection instructions
Assign sample management activities
Coordinate sample management activities
Collaborate with stakeholders
Facilitate data discrepancy resolution
Handle high priority tasks
Handle high-volume tasks
Operate in ambiguous situations
Operate in complex situations
Anticipate changing priorities
Lead efforts to improve inventory management systems
Bring external technology to department
Bring external ideas to department
Provide cross-functional support
Facilitate data reporting needs
Contribute to meetings
Supervise individual contributors
Evaluate performance of staff
Train laboratory staff
Provide leadership to staff
Provide guidance to staff
Facilitate sample transfer documentation
Review sample transfer documentation
Participate in software validation
Participate in change control activities
Work with Quality Control
Ensure data is captured in LIMS
How You'll Work.
Team & Collaboration
Cross-functional teams; Internal stakeholders; External collaborators; CROs; Third-party vendors
Communication Scope
Verbal communication; Written communication
Full Job Description
A Sr. Sample Management Specialist independently supports biobanking operations efficiently and effectively while managing sample data processes. Possesses expertise in the understanding of clinical and non-clinical study protocols and associated documentation. Manages biospecimen operations for assigned clinical/non-clinical studies and research initiatives, demonstrating strong program and data management skills and decision-making abilities with limited guidance. Works closely with clients and thoroughly understands client processes to ensure deliverables are met. The incumbent is proactive in assessing and investigating new opportunities that will lead to increased efficiencies and improved productivity with regards to biobanking operations. **In this role a typical day might include the following:** * Responsible for the interpretation of clinical/non-clinical study protocols and associated study documentation as it pertains to biospecimen management. Independently executes study reference file creation by interpreting protocols and other applicable data inputs. * Manages biosample operations for assigned clinical/non-clinical studies to ensure company deliverables are met and objectives are achieved under limited guidance. * Manages the execution of reconciliation and data cleaning of biospecimens to drive deliverables forward. * Collaborates with Data Management to draft and review Data Transfer Specifications. * Liaises with Global Clinical Development and Central Laboratories to provide input, planning, and integration of biosample operations and data transfers. * Creates and/or reviews sample collection instructions to be incorporated in the study lab manual. * Independently assigns and coordinates sample management activities for assigned programs to support high demand tasks. * Independently collaborates with internal and/or external stakeholders to facilitate data discrepancy resolution. * Proactively identifies and troubleshoots issues in area of techn
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