Sr. Sample Management Specialist (Study Lead)

Role Summary

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.

Responsibilities

• 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 technical expertise or assignment appropriately.
• Independently handles high priority and high volume tasks within the appropriate timeframe while maintaining accuracy. Operates effectively in ambiguous and complex situations. Anticipates changing priorities and initiates actions with the appropriate parties.
• Leads efforts to improve both physical and electronic inventory management systems. Pro-actively brings external cutting-edge technol¬≠ogy 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.
• Has advanced knowledge of LIMS software. Executes LIMS functions to support sample management activities.
• Has an advanced knowledge of Microsoft Excel and can independently analyze and interpret discrepancies in sample metadata with high quality.
• 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.
• Has an advanced knowledge of the ELN and uses it for data documentation.
• Proactively 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‚Äôs 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.
• Operates effectively in the face of ambiguity and change.
• 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
• Responsible for his/her own safety in the laboratory, as well as for the safety of co-workers and visitors.

Qualifications

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