Sr Sample Management Specialist

About the role

The Sr. Sample Management Specialist independently supports biobanking operations efficiently and effectively while managing sample data processes. They possess expertise in understanding clinical and non-clinical study protocols and associated documentation. They manage 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.

Responsibilities

• Interpret clinical/non-clinical study protocols and associated study documentation as it pertains to biospecimen management.
• Execute study reference file creation by interpreting protocols and other applicable data inputs.
• Manage biosample operations for assigned clinical/non-clinical studies to ensure company deliverables are met and objectives are achieved under limited guidance.
• Manage the execution of 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 provide input, planning, and integration of 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.
• Independently collaborate with internal and/or external stakeholders to facilitate data discrepancy resolution.
• Proactively identify and troubleshoot issues in area of technical expertise or assignment appropriately.
• Independently handle high priority and high-volume tasks within the appropriate timeframe while maintaining accuracy.
• Operate effectively in ambiguous and complex situations. Anticipate changing priorities and initiate actions with the appropriate parties.
• Lead efforts to improve both physical and electronic inventory management systems.
• Proactively brings external cutting-edge technology and/or ideas to the department.
• Sought out for advice in area(s) of specialization.
• Provides cross-functional support to other sample management teams, as needed.
• Facilitates data reporting needs for clinical/non-clinical/research study queries surrounding sample inventory.
• Actively contributes to meetings. May lead team meetings to discuss deliverables, resourcing, and sample management related issues.
• May supervise individual contributors, including responsibility for goal setting, performance evaluations and development.
• Trains and provides leadership and guidance to other laboratory staff.
• Facilitates sample transfer documentation and review, as applicable.
• May participate in software validation and/or change control activities.
• Works closely with Quality Control (QC) to address findings and ensure data is captured appropriately in LIMS.

Requirements

• Advanced knowledge of LIMS software.
• Executes LIMS functions to support sample management activities.
• Advanced knowledge of Microsoft Excel and can independently analyze and interpret discrepancies in sample metadata with high quality.
• Works closely with Quality Control (QC) to address findings and ensure data is captured appropriately in LIMS.
• Advanced knowledge of the ELN and uses it for data documentation.
• Pro-actively ensures a state of audit readiness.
• Actively participates in the preparation of supporting documents for Quality Assurance & Auditing (QAA), as applicable.
• Participates in study audit activities.
• Maintains effective verbal and written communication both internally and with external collaborators and vendors.
• Communicates with CRO’s and third-party vendors to support sample management responsibilities.
• Ensures compliance and proper documentation in accordance with working instructions, SOPs, and applicable regulations.
• Conducts him/herself with professionalism and integrity while consistently driving results forward.
• Pro-actively collaborates and leverages relationships within and across departments.
• Communicates and collaborates effectively across levels and groups in different settings, conveying information in a compelling and articulate way.
• Drives conversation and actively seeks out and/or creates opportunities to develop their skills and/or knowledge base to further grow their depth and breadth.

Qualifications

• Bachelor’s degree with 6 years of relevant post-degree laboratory experience or a Master’s degree with 4 years of relevant post-degree laboratory experience.