Sr. Sample Management Specialist (Study Lead)

Role Summary

Sr. Sample Management Specialist (Study Lead) independently supports biobanking operations and manages sample data processes. Possesses expertise in clinical and non-clinical study protocols and documentation. Manages biospecimen operations for assigned studies and research initiatives with strong program and data management skills, working with limited guidance. Proactively identifies opportunities to increase efficiencies in biobanking operations.

Responsibilities

• Interpret clinical/non-clinical study protocols and associated documentation as it pertains to biospecimen management; independently execute study reference file creation by interpreting protocols and data inputs.
• Manage biosample operations for assigned studies to meet deliverables and objectives under limited guidance.
• Execute reconciliation and data cleaning of biospecimens to drive deliverables forward.
• Collaborate with Data Management to draft and review Data Transfer Specifications.
• Liaise with Global Clinical Development and Central Laboratories to plan and integrate biosample operations and data transfers.
• Create and/or review sample collection instructions to be incorporated in the study lab manual.
• Independently assign and coordinate sample management activities for assigned programs to support high demand tasks.
• Collaborate with internal and external stakeholders to facilitate data discrepancy resolution.
• Identify and troubleshoot issues in area of expertise appropriately.
• Independently handle high priority/high volume tasks within the appropriate timeframe while maintaining accuracy; operate effectively in ambiguous/complex situations and anticipate changing priorities.
• Lead efforts to improve physical and electronic inventory management systems; introduce external technology/ideas; seek advice in specialization.
• Provide cross-functional support to other sample management teams as needed.
• Facilitate data reporting for study queries regarding sample inventory.
• Contribute to meetings and may lead team meetings on deliverables, resourcing, and issues.
• May supervise contributors, including goal setting, performance evaluations, and development.
• Train and provide leadership to other laboratory staff.
• Demonstrate advanced knowledge of LIMS; execute LIMS functions to support sample management.
• Exhibit advanced knowledge of Microsoft Excel; analyze and interpret discrepancies in sample metadata.
• Facilitate sample transfer documentation and review as applicable.
• May participate in software validation and/or change control activities.
• Work with Quality Control to address findings and ensure data is captured in LIMS.
• Have advanced knowledge of the ELN and use it for data documentation.
• Proactively ensure audit readiness; participate in QA&A and study audit activities as applicable.
• Maintain effective verbal and written communication with internal teams, external collaborators, and vendors; interact with CROs and third-party vendors to support sample management.
• Ensure compliance and proper documentation per working instructions, SOPs, and regulations.
• Conduct themselves with professionalism and integrity while driving results; collaborate across departments; operate in ambiguity and change.
• Communicate and collaborate effectively across levels and groups; develop skills and knowledge to grow depth and breadth.
• Take responsibility for personal safety in the laboratory and for the safety of others.

Qualifications

• Typically, 6 plus years of relevant post-degree laboratory experience for Bachelor's degree
• Typically, 4 plus years of relevant post-degree laboratory experience for Master's degree