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 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.

This role may be for you if you have:

• 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 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.

• 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.

To be considered for this role, you must have a 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.