Manager, Sample Services

Join The CTI Team•Cincinnati, OH

10d

About The Position

Oversee the daily operations of the Samples Services, including sample collection, processing, storage, and distribution, to ensure efficient, accurate, and compliant handling of biospecimens. Lead the Sample Services team in performing all functions related to sample management, ensuring compliance with internal and external standards. Help manage the logistics, including shipping, tracking, and inventory of samples, in accordance with project timelines and requirements. Assist College of American Pathologists (CAP) Director in overseeing development of Sample Services and sample management core policies for successful and compliant conduct of clinical trials and Sample Services projects. Implement and maintain Standard Operating Procedures (SOPs), and policies in alignment with industry standards and best practices. Assist in regular audits and quality checks to ensure the integrity, safety, and confidentiality of biospecimens. Develops and maintains effective key performance indicators (KPIs) and quality indicators relative to Sample Services operations. Manage sample storage inventory and ensure quality control, including creating sample batches, printing labels, and labeling tubes and batches. Supervise and mentor a team of Sample Services staff, providing training and professional development opportunities to ensure high performance and career growth. Collaborate with the CTI Leadership to recruit, hire, and onboard new team members to provide expertise, support, and sample management services to CTI’s portfolio of clinical trials and Sample Services projects. Foster a collaborative and motivated team environment focused on operational excellence and continuous improvement. Support the receipt, unpacking, and processing of incoming clinical specimens, preparing them for testing through tasks such as aliquoting and relabeling. Resolve and document issues related to incomplete or unacceptable specimens. Ensure proper performance of Sample Services equipment and appropriate control monitoring to provide optimum specimen conditions. Identify and implement opportunities for operational improvement, including workflow optimization and automation in biospecimen management processes. Stay informed about industry trends, emerging technologies, and regulatory changes to proactively adjust Sample Services practices. Oversee sample lifecycle management from acquisition to archival, maintaining accurate records and databases related to sample tracking, chain of custody, and compliance. Perform the data entry and data verification in the LIMS database. Generate reports on inventory status, usage, and operational efficiency for internal and external stakeholders. Ensure Sample Services operates in a safe and compliant manner, in accordance with OSHA and other relevant safety regulations. Conduct risk assessments and oversee the implementation of corrective actions to maintain a safe working environment for the Sample Services staff. Assist the CTI Leadership in managing the Sample Services budget, ensuring that resources are allocated effectively to meet operational goals and project demand. Support clinical studies including, but not limited to, assisting in the development of Laboratory Specification Plans, Sample Services Specification Plans, and Material Transfer Agreements. Optimize the use of Sample Services space, equipment, and materials to achieve cost-efficiency and scalability to align with business needs. Oversee administrative functions of the Sample Services and management of supplies, ensuring sufficient inventory for daily operations.

Requirements

Proven ability to lead and develop high-performing teams, make informed decisions, and solve problems efficiently.
Expertise in continuous improvement and process optimization.
Proficient in developing and analyzing KPIs.
Proficient in accurate biospecimen tracking and inventory management.
Strong knowledge of regulatory frameworks such as CAP, CLIA, HIPAA, GLP, GCP, and GDPR.
Excellent interpersonal skills for working in rapid-pace startup and growth environment with cross-functional teams.
Strong focus on maintaining an organized and safe work environment, with experience implementing safety protocols and ensuring compliance.
Ability to work independently with minimal supervision, handle multiple tasks, detail oriented focus, and prioritize effectively.
Ability to stay current with trends, technologies, and regulatory changes, adapting as necessary to further CTI’s Clinical Initiatives.
BS or MS in biological science, clinical laboratory science, medical technology, or other relevant field.
At least 2 years of experience as a Biorepository supervisor leading teams and managing sample services, or related experience in high-volume biopharmaceutical or clinical laboratories, or biobanks, with high-volume management experience.

Responsibilities

Oversee the daily operations of the Samples Services, including sample collection, processing, storage, and distribution.
Lead the Sample Services team in performing all functions related to sample management, ensuring compliance with internal and external standards.
Manage the logistics, including shipping, tracking, and inventory of samples, in accordance with project timelines and requirements.
Assist College of American Pathologists (CAP) Director in overseeing development of Sample Services and sample management core policies.
Implement and maintain Standard Operating Procedures (SOPs), and policies in alignment with industry standards and best practices.
Assist in regular audits and quality checks to ensure the integrity, safety, and confidentiality of biospecimens.
Develops and maintains effective key performance indicators (KPIs) and quality indicators relative to Sample Services operations.
Manage sample storage inventory and ensure quality control, including creating sample batches, printing labels, and labeling tubes and batches.
Supervise and mentor a team of Sample Services staff, providing training and professional development opportunities.
Collaborate with the CTI Leadership to recruit, hire, and onboard new team members.
Foster a collaborative and motivated team environment focused on operational excellence and continuous improvement.
Support the receipt, unpacking, and processing of incoming clinical specimens, preparing them for testing through tasks such as aliquoting and relabeling.
Resolve and document issues related to incomplete or unacceptable specimens.
Ensure proper performance of Sample Services equipment and appropriate control monitoring to provide optimum specimen conditions.
Identify and implement opportunities for operational improvement, including workflow optimization and automation in biospecimen management processes.
Stay informed about industry trends, emerging technologies, and regulatory changes to proactively adjust Sample Services practices.
Oversee sample lifecycle management from acquisition to archival, maintaining accurate records and databases related to sample tracking, chain of custody, and compliance.
Perform the data entry and data verification in the LIMS database.
Generate reports on inventory status, usage, and operational efficiency for internal and external stakeholders.
Ensure Sample Services operates in a safe and compliant manner, in accordance with OSHA and other relevant safety regulations.
Conduct risk assessments and oversee the implementation of corrective actions to maintain a safe working environment.
Assist the CTI Leadership in managing the Sample Services budget, ensuring that resources are allocated effectively.
Support clinical studies including, but not limited to, assisting in the development of Laboratory Specification Plans, Sample Services Specification Plans, and Material Transfer Agreements.
Optimize the use of Sample Services space, equipment, and materials to achieve cost-efficiency and scalability.
Oversee administrative functions of the Sample Services and management of supplies, ensuring sufficient inventory for daily operations.