Manager, Sample Services - level dependent upon experience

What You'll Do

• Oversight of daily operations including sample collection, processing, storage, and distribution to ensure efficient, accurate, and compliant handling of biospecimens.
• Leadership of the Sample Services team in performing all functions related to sample management, ensuring compliance with internal and external standards.
• Management of logistics, including shipping, tracking, and inventory of samples, in accordance with project timelines and requirements.
• Assistance in overseeing the development of Sample Services and sample management core policies for clinical trials and Sample Services projects.
• Implementation and maintenance of Standard Operating Procedures (SOPs) and policies in alignment with industry standards and best practices.
• Regular audits and quality checks to ensure the integrity, safety, and confidentiality of biospecimens.
• Development and maintenance of key performance indicators (KPIs) and quality indicators relative to Sample Services operations.
• Management of sample storage inventory and ensuring quality control, including creating sample batches, printing labels, and labeling tubes and batches.
• Supervision and mentorship of a team of Sample Services staff, providing training and professional development opportunities to ensure high performance and career growth.
• Collaboration 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.
• Fostering a collaborative and motivated team environment focused on operational excellence and continuous improvement.
• Supporting the receipt, unpacking, and processing of incoming clinical specimens, preparing them for testing through tasks such as aliquoting and relabeling.
• Resolving and documenting issues related to incomplete or unacceptable specimens.
• Ensuring proper performance of Sample Services equipment and appropriate control monitoring to provide optimum specimen conditions.
• Identifying and implementing opportunities for operational improvement, including workflow optimization and automation in biospecimen management processes.
• Staying informed about industry trends, emerging technologies, and regulatory changes to proactively adjust Sample Services practices.
• Performing sample lifecycle management from acquisition to archival, maintaining accurate records and databases related to sample tracking, chain of custody, and compliance.
• Data entry and data verification in the LIMS database.
• Generating reports on inventory status, usage, and operational efficiency for internal and external stakeholders.
• Ensuring Sample Services operates in a safe and compliant manner, in accordance with OSHA and other relevant safety regulations.
• Conducting risk assessments and overseeing the implementation of corrective actions to maintain a safe working environment for the Sample Services staff.
• Assisting the CTI Leadership in managing the Sample Services budget, ensuring that resources are allocated effectively to meet operational goals and project demand.
• Supporting clinical studies, including assisting in the development of Laboratory Specification Plans, Sample Services Specification Plans, and Material Transfer Agreements.
• Optimizing the use of Sample Services space, equipment, and materials to achieve cost-efficiency and scalability to align with business needs.
• Overseeing 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.
• Proficiency in developing and analyzing KPIs.
• Strong knowledge of regulatory frameworks such as CAP, CLIA, HIPAA, GLP, GCP, and GDP.
• Excellent interpersonal skills for working in a rapid-pace startup and growth environment with cross-functional teams.
• A 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, and prioritize effectively.
• An ability to stay current with trends, technologies, and regulatory changes, adapting as necessary to further CTI’s Clinical Initiatives.
• A 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.
• We have an unparalleled culture – 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).