Sr Sample Management Specialist

About the role

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.

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 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

• 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.
• 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 CROs 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

• Has a Bachelors degree with 6 years of relevant post-degree laboratory experience or a Masters degree with 4 years of relevant post-degree laboratory experience.