Centralized Clinical Trial Manager (CCTM)
Job Title: Centralized Clinical Trial Manager (CCTM)
Location: Bangalore or Chennai, India
Work Model: Office or Home (Hybrid/Remote Eligible)
Employment Type: Full-Time
Job Requisition ID: JR145001
Company: ICON plc
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and therapies that improve patient outcomes worldwide.
Driven by its core values of Integrity, Collaboration, Agility, and Inclusion, ICON partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality clinical research solutions across the drug development lifecycle.
Position Overview
ICON is seeking an experienced Centralized Clinical Trial Manager (CCTM) to provide centralized oversight of clinical trial execution, monitoring quality, and operational compliance across assigned studies.
The CCTM acts as an extension of the Clinical Trial Management team, focusing on review and approval of monitoring visit reports, oversight of study metrics, management of protocol deviations, escalation of risks, and coordination between Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), Project Managers (PMs), and study teams.
This role plays a critical part in ensuring clinical trial quality, patient safety, regulatory compliance, and timely study delivery.
Key Responsibilities
Monitoring Visit Report (MVR) Review & Quality Oversight
Review and approve monitoring visit reports in accordance with:
Study Protocols
ICON SOPs
Sponsor SOPs
Annotated Monitoring Report Guidelines
Ensure reports are:
Accurate
Complete
Consistent across sites and visits
Compliant with regulatory and sponsor requirements
Minimize reporting errors and identify quality concerns.
Ensure report approval timelines are met according to contractual obligations and SOP requirements.
Clinical Trial Oversight
Provide centralized oversight of ongoing clinical studies.
Monitor study progress and identify operational risks.
Support successful execution of clinical trial deliverables.
Ensure quality standards are maintained across study activities.
Action Item & Protocol Deviation Management
Track and follow up on:
Open Action Items
Protocol Deviations
Site Compliance Issues
Monitoring Findings
Coordinate resolution activities with study teams.
Escalate unresolved or high-risk issues appropriately.
Ensure timely closure of action items according to study requirements.
Stakeholder Coordination
Serve as a liaison between:
Clinical Research Associates (CRAs)
Clinical Trial Managers (CTMs)
Project Managers (PMs)
Clinical Operations Teams
Sponsor Teams
Facilitate communication and issue resolution.
Support collaboration across functional teams to maintain study quality and timelines.
Patient Safety & Risk Escalation
Review monitoring reports to identify:
Safety trends
Emerging risks
Site performance concerns
Compliance issues
Escalate significant findings impacting:
Patient Safety
Data Integrity
Regulatory Compliance
Study Delivery
Support proactive risk mitigation activities.
Clinical Systems & Metrics Oversight
Perform regular oversight of:
OMR Systems
ICO Trial Platforms
Sponsor CTMS (Clinical Trial Management Systems)
Vendor Tracking Systems
Monitor key performance indicators (KPIs), including:
Monitoring Visit Report (MVR) Timelines
Follow-Up Letter (FUL) Timelines
Open Action Items
Quality Metrics
Protocol Deviation Trends
Ensure compliance with study-specific and organizational performance standards.
Study Team Support & Process Improvement
Attend project meetings when required.
Provide recommendations to improve:
Monitoring report quality
Study processes
Compliance performance
Operational efficiency
Contribute to continuous improvement initiatives and best practices.
Regulatory Compliance
Ensure clinical trial activities align with:
ICH-GCP Guidelines
Local Regulatory Requirements
Sponsor Expectations
Company SOPs
Maintain inspection and audit readiness.
Promote quality-focused trial conduct.
Training & Professional Development
Complete required training programs.
Support knowledge sharing and operational excellence initiatives.
Contribute to creating a culture of quality, accountability, and continuous improvement.
Required Qualifications
Education
Required
Bachelor’s Degree in:
Life Sciences
Pharmacy
Nursing
Biotechnology
Healthcare
Related Scientific Discipline
Preferred
Master's Degree or Advanced Scientific Qualification
Required Experience
Clinical Research Experience
Minimum 8–10 years of Clinical Research experience.
Mandatory Monitoring Experience
At least 5 years of on-site monitoring experience as a:
Clinical Research Associate (CRA)
Senior CRA
Lead CRA
Similar Clinical Monitoring Role
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