Clinical Trial Laboratory Manager

The Division of Clinical Research provides infrastructure support for all aspects of clinical research. UT MD Anderson has the nation’s largest cancer clinical trials program enrolling patients in Texas and beyond through our Cancer Network® partners across the country. UT MD Anderson is devoted to the needs and protection of all those participating in or conducting clinical research while maintaining high ethical standards and compliance with all regulatory policies. The Clinical Trial Laboratory Manager provides leadership and oversight for all clinical trial laboratory operations, ensuring alignment with institutional goals, regulatory compliance, and best practices. This position supervises Clinical Trial Technicians, Clinical Trial Laboratory Coordinators, and Clinical Trial Laboratory Supervisors, fostering a culture of excellence, efficiency, and collaboration. The Clinical Trial Laboratory Manager is responsible for optimizing workflows, implementing quality control measures, and ensuring adherence to safety and regulatory requirements. Additionally, they oversee personnel management, administrative operations, and stakeholder engagement to support the successful execution of clinical research protocols. Through strategic leadership and process standardization, the Clinical Trial Laboratory Manager drives operational excellence and continuous improvement in research laboratory functions. The ideal Clinical Trial Laboratory Manager holds a Bachelor’s degree in a science-related field and possesses experience with blood collection and/or laboratory processing. Prior experience with clinical trials or clinical research and a large laboratory environment is required. The candidate is highly adaptable and able to effectively respond to changing workflows. Salary range: Minimum $45.67 - Midpoint $56.97 - Maximum $68.27 per hour, based on a 40‑hour work week. Typical work schedule: Onsite Monday – Friday, 8:00am – 4:30pm. Work location: Texas Medical Center. KEY FUNCTIONS 1. Clinical Trial Laboratory Oversight & Compliance (30%) Direct and manage all clinical trial laboratory activities, ensuring compliance with institutional, state, and federal regulations. Oversee pharmacologic sampling, processing, and shipment processes, ensuring protocol adherence and data integrity. Coordinate with research teams, lab staff, and regulatory entities to ensure accuracy in protocol documents, data collection sheets, and scheduling. Implement and standardize laboratory protocols, integrating them into the LIMS (ARMADA) system for efficiency and traceability. Maintain oversight of clinical trials personnel, providing mentorship, performance guidance, and operational support. 2. Quality Assurance, Process Optimization & Safety (30%) Develop, implement, and monitor quality control measures, ensuring adherence to clinical trial standards and laboratory best practices. Oversee laboratory compliance with safety protocols, including hazardous material handling, regulatory documentation, and regulatory requirements. Identify key performance indicators for continuous quality improvement and address deviations through corrective action plans. Ensure technical competency among staff through ongoing training, standardization of procedures, and process audits. Stay current on new laboratory technologies, integrating advancements to enhance accuracy, efficiency, and compliance. 3. Leadership, Team Development & Personnel Management (20%) Supervise and provide leadership for Clinical Trial Technicians, Clinical Trial Laboratory Coordinators, and Clinical Trial Laboratory Supervisors. Oversee recruitment, onboarding, training, and performance evaluations for laboratory personnel, ensuring professional development opportunities. Establish clear performance expectations, administer policies, and manage employee relations, including disciplinary actions when necessary. Foster a culture of communication, teamwork, and professional growth across all laboratory staff and research teams. Promote cross‑functional collaboration with other departments and stakeholders to align laboratory operations with institutional goals. 4. Administrative & Stakeholder Engagement (20%) Serve as the primary liaison between the laboratory, study sponsors, clinical teams, and regulatory agencies to ensure seamless clinical trial execution. Manage laboratory resource allocation, including budgeting, inventory control, and procurement of trial‑related supplies and kits. Oversee administrative workflows, ensuring efficiency in protocol activation, amendments, and study‑specific documentation. Lead internal and external audits, addressing compliance gaps and implementing corrective actions as needed. Represent the laboratory in institutional meetings, advocating for process improvements and resource needs. 5. Other duties as assigned. EDUCATION Required: Bachelor’s Degree in Public Health, Healthcare Administration or related scientific field. Preferred: Master’s Degree in Public Health, Healthcare Administration or related scientific field. WORK EXPERIENCE Required: Six years of experience with clinical research studies, including a minimum of two years of supervisory experience. Experience can be substituted for additional education on a one‑to‑one basis. Preferred: Five years of required experience with two years of supervisory experience for those holding the preferred degree. Preferred: Prior experience with blood collection and/or laboratory processing, and experience in a large laboratory environment. LICENSES AND CERTIFICATIONS Required: Certification issued by the American Society of Clinical Pathology (ASCP), including but not limited to Phlebotomy (PBT), Medical Laboratory Technician (MLT), or Medical Laboratory Assistant (MLA). Required: CCRC – Certified Clinical Research Coordinator. Required: CCRP – Certified Clinical Research Professional. Required: CCRA – Certified Clinical Research Associate. Other requirements: Must pass pre‑employment skills test as required and administered by Human Resources. The University of Texas MD Anderson Cancer Center offers benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition. This position may be responsible for maintaining the security and integrity of critical infrastructure as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment. It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law. #J-18808-Ljbffr