Manager, Sample Services

CTI Clinical Trial and Consulting Services•Cincinnati, OH

11d

About The Position

This role oversees the daily operations of the Sample Services department, ensuring efficient, accurate, and compliant handling of biospecimens. The Manager will lead the team in all sample management functions, manage logistics, assist in policy development, implement SOPs, conduct audits, and develop KPIs. Responsibilities also include managing sample storage inventory, supervising and mentoring staff, fostering a collaborative team environment, supporting specimen processing, ensuring equipment performance, identifying operational improvements, staying informed about industry trends, overseeing sample lifecycle management, performing data entry and verification, generating reports, ensuring safety and compliance, conducting risk assessments, assisting with budget management, supporting clinical studies, optimizing space and resource utilization, and overseeing administrative functions and supply management.

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, 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