JOB SUMMARY

The Clinical Research Quality Control Manager is a senior leader responsible for the strategic oversight, planning, and execution of all quality control activities within the clinical research unit. This role ensures that clinical trial processes, documentation, and regulatory submissions consistently meet internal standards and external regulatory requirements. The manager leads QC reviews, identifies non-conformances, drives process improvements, and mentors QC staff.

RESPONSIBILITIES

Strategic Leadership & Oversight

• Develop, implement, and maintain a comprehensive quality control program for clinical research activities. 
• Lead and mentor QC staff, providing guidance, training, and performance management. 
• Serve as the subject matter expert for QC processes, regulations, and best practices. 

Quality Control Operations

• Oversee QC review of clinical documents (source documentation, regulatory binder, pharmacy binder, laboratory binder, presentation materials, and clinical sections of regulatory submissions). 
• Ensure all clinical processes comply with applicable regulations, SOPs, laboratory manuals, and study protocols. 
• Oversee alignment of processing forms and shipping manifests with SOPs and protocols. 
• Attend key study visits to ensure quality and compliance. 
• Follow up on outstanding source documentation review issues with designated staff. 
• Maintain and utilize QC tracking logs for live QC activities. 

Continuous Improvement & Risk Mitigation 

• Identify non-conformances during clinical trial conduct and lead root cause analyses. 
• Develop and implement risk mitigation strategies and corrective action plans. 
• Drive ongoing process improvement initiatives. 

Training & SOP Development

• Lead the writing and review of clinical quality-related SOPs. 

Regulatory & Compliance

• Ensure correct IRB-approved informed consent forms and subject source documents are used. 
• Communicate with operational departments regarding project status and issues. 
• Ensure compliance with current Good Clinical Practices (cGCPs) and corporate policies. 

Strategic Planning & Vision

• Develop and execute the long-term vision and strategy for quality control across all clinical research programs. 
• Align QC objectives with organizational goals and regulatory trends. 

Organizational Leadership

• Lead and manage multiple QC teams or units across sites, ensuring consistency and excellence in QC practices. 
• Oversee recruitment, development, and retention of QC staff; set performance standards and conduct evaluations. 

Cross-Functional Collaboration

• Serve as the primary QC liaison to executive leadership, regulatory affairs, clinical operations, and external partners. 
• Lead cross-functional committees focused on quality, compliance, and process improvement. 

Other Duties 

• Perform other QC-related duties as assigned. 

TRAVELING

Between Corporate New Jersey and New York locations, as needed.

Salary Range: $85,000–$95,000 annually. Final compensation is based on skills, experience, location, and overall expertise. 

• Education: Bachelor’s degree in a relevant field (e.g., Life Sciences, Chemistry, Biology, Nursing, or related discipline) required; advanced degree preferred. 
• Experience: Minimum 5 years of progressive experience in clinical research quality control or related field, with at least 2 years in a leadership or management role. 
• Deep knowledge of clinical research processes, regulatory requirements, and QC methodologies. 
• Proven leadership and team management abilities. 
• Excellent communication, analytical, and problem-solving skills. 
• Strong organizational and project management skills. 
• Ability to provide accurate documentation and drive process improvements.