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. Clinical Trial Laboratory Manager 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 manager is responsible for optimizing workflows, implementing quality control measures, and ensuring adherence to safety and regulatory requirements, as well as overseeing personnel management, administrative operations, and stakeholder engagement to support successful execution of clinical research protocols. 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 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 and regulatory documentation. 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 obtained from data gathering, laboratory, or related field to include two years of supervisory experience; or with preferred degree, five years of required experience to include two years supervisory experience. May substitute required education degree with additional years of equivalent experience on a one‑to‑one basis. Successful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience. Completion of both programs can be substituted for a maximum of two years of supervisory or management experience. Preferred: Prior experience with blood collection and/or laboratory processing; experience with clinical trials or clinical research and have experience working 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. Benefits Employer‑paid medical coverage starting day one for employees working 30+ hours per week, plus optional group dental, vision, life, AD&D, and disability insurance. Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options. Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups. Defined‑benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer‑paid life and reduced salary protection programs. The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition. Security and Integrity 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. Equal Employment Opportunity Statement 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 or 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. Additional Information Requisition ID: 181064 Employment Status: Full‑Time Employee Status: Regular Work Week: Days Minimum Salary: US Dollar (USD) 95,000 Midpoint Salary: US Dollar (USD) 118,500 Maximum Salary: US Dollar (USD) 142,000 FLSA: Exempt and not eligible for overtime pay Fund Type: Soft Work Location: Onsite Pivotal Position: Yes Referral Bonus Available: Yes Relocation Assistance Available: Yes #J-18808-Ljbffr