Clinical Trial Laboratory Manager
• Employer-paid medical coverage starting day one for employees working 30+ hours/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. 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 Public Health, Healthcare Administration or related scientific field.
- Preferred: Master's Degree Public Health, Healthcare Administration or related scientific field.
- Required: Six years 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.
- Required: Certification issued by the American Society of Clinical Pathology (ASCP). Included but not limited to Phlebotomy (PBT), Medical Laboratory Technician (MLT), or Medical Laboratory Assistant (MLA). or
- Required: CCRC - Certified Clinical Research Coordinator or
- Required: CCRP - Certified Clinical Research Professional or
- Required: CCRA - Cert Clin Research Assoc
- 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
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