Manager, Lab Central Monitoring
Company: IQVIA
Location: Thane, India
Department: Centralized Monitoring / Clinical Operations
Job Type: Full-Time
Work Mode: Hybrid
JOB OVERVIEW
The Manager, Lab Central Monitoring is responsible for leading and managing a team of Centralized Monitoring Project Coordinators (CPCs), ensuring the timely and high-quality delivery of centralized monitoring activities across clinical studies. The role involves team leadership, resource planning, quality management, staff development, project coordination, risk management, SOP compliance, root cause analysis, CAPA implementation, performance monitoring, and collaboration with global clinical operations teams to ensure compliance with ICH-GCP guidelines and sponsor requirements.
KEY RESPONSIBILITIES
Team Leadership & People Management
Lead and manage a team of Centralized Monitoring Project Coordinators (CPCs).
Plan, assign, and supervise daily work activities.
Coach, mentor, and develop team members.
Conduct performance evaluations and provide regular feedback.
Support employee development and career progression.
Address employee relations issues and performance concerns.
Approve HR-related actions in accordance with company policies.
Resource Planning & Workforce Management
Allocate staff based on project requirements and experience.
Monitor resource utilization across assigned studies.
Track staff assignments and workload distribution.
Ensure adequate staffing for ongoing and upcoming projects.
Report staffing metrics to management.
Training & Staff Development
Participate in recruitment, candidate interviews, and onboarding.
Coordinate onboarding activities with Human Resources.
Ensure completion of mandatory SOP and compliance training.
Monitor execution of training plans.
Provide mentoring and continuous learning opportunities.
Ensure staff have appropriate system access and study-specific training.
Project & Operational Management
Build strong relationships with global project and operational teams.
Collaborate with sponsors and internal stakeholders.
Ensure consistent global delivery of centralized monitoring services.
Support sponsor-specific processes and standards.
Monitor project quality and productivity.
Drive operational excellence across assigned studies.
Quality Management
Conduct routine quality reviews and mini-audits.
Monitor staff output for accuracy and compliance.
Identify quality issues and performance gaps.
Ensure inspection-ready documentation.
Maintain compliance with company quality standards.
Risk Management & CAPA
Lead investigations related to quality incidents.
Perform Root Cause Analysis (RCA).
Develop and implement Corrective and Preventive Action (CAPA) plans.
Identify operational risks and mitigation strategies.
Monitor CAPA effectiveness and follow-up activities.
Compliance & Regulatory Oversight
Ensure compliance with ICH-GCP guidelines.
Follow company Standard Operating Procedures (SOPs).
Maintain regulatory compliance across centralized monitoring activities.
Support internal and external audits.
Ensure adherence to sponsor requirements and industry regulations.
Performance Monitoring & Continuous Improvement
Track departmental and individual performance metrics.
Prepare performance and operational reports.
Monitor KPIs and productivity trends.
Participate in departmental continuous improvement initiatives.
Recommend workflow and process improvements.
Support operational efficiency and service quality enhancement.
EDUCATIONAL QUALIFICATIONS
Required
High School Diploma or equivalent.
Preferred
Bachelor's Degree in:
Life Sciences
Pharmacy
Nursing
Biotechnology
Biological Sciences
Clinical Research
Healthcare
Or a related discipline
EXPERIENCE REQUIREMENTS
Required
6–9 years of relevant experience in:
Clinical Research
Clinical Operations
Centralized Monitoring
Clinical Trial Management
3–5 years of experience in:
Line Management
Team Leadership
People Management
Preferred
Experience managing centralized monitoring teams.
Clinical Research Organization (CRO) experience.
Experience with global clinical studies.
Experience in quality management and CAPA.
Experience with staff development and performance management.
Uttar Pradesh :
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