Manager, Sample Services - level dependent upon experience

CTI Clinical Trial Services, Inc.

Cincinnati, OH

What You'll Do

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

What You'll Bring

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

Why CTI?

We support career progression - 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
Our culture is unparalleled - Click here to learn more about "The CTI Way"
We think globally and act locally - We have a global philanthropic program supporting our team's efforts to improve their local communities (Click here to learn more about our "CTI Cares" program)

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( or from our verified LinkedIn page.

Please Note

We will never communicate with you directly via Microsoft Teams Messaging or text message
We will never ask for your bank account information at any point during the recruitment process

Equal Opportunity Employer/Veterans/Disabled

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Vacancy posted 4 days ago

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