Job Title: Centralized Clinical Trial Manager (CCTM)
Location: Bangalore or Chennai, India (Office-Based or Home-Based)
Job Type: Full-Time
Company: ICON plc
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and treatments that improve patient outcomes worldwide. Guided by integrity, collaboration, agility, and inclusion, ICON partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality clinical research solutions across all phases of clinical development.
Position Overview
ICON is seeking an experienced Centralized Clinical Trial Manager (CCTM) to join its Clinical Operations team. In this role, you will provide centralized oversight of clinical trial monitoring activities, ensuring the quality, consistency, and compliance of site visit reports, action items, protocol deviations, and study deliverables. Acting as an extension of the Clinical Trial Manager (CTM) team, you will collaborate closely with CRAs, Project Managers, Sponsors, and study teams to support risk mitigation, patient safety, and successful clinical trial execution.
This position is ideal for professionals with strong Clinical Trial Management and On-Site Monitoring experience who are passionate about quality oversight, operational excellence, and centralized monitoring strategies.
Key Responsibilities
Review and approve monitoring visit reports in accordance with study protocols, sponsor requirements, ICON SOPs, and regulatory guidelines.
Ensure monitoring reports are accurate, complete, consistent, and delivered within established timelines.
Act as an extension of the Clinical Trial Management team for centralized review and approval of site monitoring documentation.
Monitor report quality trends and provide recommendations for continuous improvement.
Follow up on open action items, protocol deviations, and site issues to ensure timely resolution.
Serve as a liaison between Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), Project Managers (PMs), and study stakeholders.
Identify, assess, and escalate operational risks, quality concerns, compliance issues, and patient safety trends.
Conduct oversight of clinical trial management systems and monitoring platforms to ensure compliance with study metrics and quality standards.
Review key study performance indicators, including monitoring visit report timelines, follow-up letters, protocol deviations, and action item completion.
Participate in project meetings and provide strategic recommendations to improve study quality and operational performance.
Collaborate with study teams to ensure adherence to contractual obligations, sponsor expectations, and regulatory requirements.
Support inspection readiness and audit preparedness activities.
Contribute to process improvement initiatives and promote a culture of operational excellence within Clinical Operations.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Healthcare, or a related discipline.
Advanced degree preferred.
Minimum 8–10 years of clinical research experience.
At least 5 years of hands-on On-Site Monitoring experience as a Clinical Research Associate (CRA) or equivalent.
Experience in Clinical Trial Management, Clinical Operations, or Centralized Monitoring functions.
Strong understanding of clinical trial conduct, monitoring methodologies, and regulatory requirements.
Thorough knowledge of ICH-GCP, FDA, EMA, and applicable local regulatory guidelines.
Strong analytical, problem-solving, and risk assessment skills.
Excellent communication, stakeholder management, and leadership abilities.
Ability to work independently while managing multiple studies and competing priorities.
Technical Skills
Clinical Trial Management
Centralized Monitoring
Monitoring Visit Report Review
Site Oversight & Quality Management
Clinical Operations
Risk-Based Monitoring (RBM)
Protocol Deviation Management
Corrective & Preventive Actions (CAPA)
Clinical Trial Management Systems (CTMS)
Action Item Tracking & Resolution
Clinical Data Review
Patient Safety Oversight
Regulatory Compliance
Audit & Inspection Readiness
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