Team Lead, Biorepository - Biospecimen Operations
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LabConnect, LLC
Cleveland, OH (In Person)
Full-Time
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Job Description
Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions. Job Summary The Clinical Sample Specialist Team Lead provides daily operational leadership and technical oversight for Clinical Sample Specialists within the Biospecimen Operations department. This role is responsible for ensuring the accurate, timely, and compliant handling of clinical specimens while supporting team performance, training, quality initiatives, and continuous process improvement. The Team Lead serves as a subject matter expert in sample management processes, acts as the primary escalation point for operational issues, and partners closely with management and cross functional departments including Client Services (CS), Sample Tracking Solutions (STS), and Clinical Trial Materials (CTM). Essential Duties and Responsibilities Perform all duties of Clinical Sample Specialist I, II, and III with a high level of proficiency. Provide day to day leadership, guidance, and direction to a team of Clinical Sample Specialists. Coordinate daily workflow, assign tasks, and ensure adequate coverage to meet operational demands. Serve as the primary point of escalation for specimen discrepancies, shipping issues, and process deviations. Ensure tasks and data are completed accurately, in compliance with Good Documentation Practices (GDP), IATA requirements, and universal safety precautions. Oversee specimen receipt, accessioning, labeling, storage, processing, and shipment activities. Verify completion and accuracy of daily and end of day checklists. Review and approve sample shipments, including same day, scheduled, ad hoc, and destruction shipments. Provide training, coaching, and competency assessments for Clinical Sample Specialists, including annual competencies. Support onboarding and ongoing development of new and existing team members. Participate in and support quality event reporting, investigations, and corrective and preventive actions (CAPAs). Identify process gaps and actively contribute to process improvement and operational efficiency initiatives. Assist management with performance feedback, attendance tracking, and workforce planning. Enter and review shipment and operational data in LIMS, ERP, and other applicable systems for tracking and billing purposes. Ensure proper handling, recycling, and disposal of dry ice, biological samples, and shipping materials. Maintain inventory levels and ensure supplies are adequately stocked. Attend required meetings and training courses, including IATA and dangerous goods training. Complete at least 6 hours of continuing education annually. Provide departmental coverage and operational oversight in the absence of a supervisor or manager. Perform other duties as assigned by management. Education and Experience High school diploma or GED required. Associate's degree with at least 2 years of clinical research, central laboratory, biorepository, or related experience or BA/BS in laboratory science, health science, or business preferred. Minimum of six months' experience as a Clinical Sample Specialist III or equivalent experience required. Previous experience providing training, workflow coordination, or informal leadership in a laboratory or biospecimen environment strongly preferred. Skills and Ability Demonstrated leadership, coaching, and team facilitation skills. Strong problem solving and decision-making abilities. Excellent communication, organizational, and interpersonal skills. Ability to read and interpret safety rules, SOPs, and procedure manuals. Proficient in writing routine reports and documentation. Confidence in public speaking and leading small group discussions or trainings. Advanced troubleshooting skills related to specimen management and logistics. Proficient in Microsoft Word and Excel. Strong working knowledge of Laboratory Information Management Systems (LIMS) and related operational systems.