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Centralized Clinical Trial Manager (Cctm)

ICON PLC
8-10 years
Not Disclosed
Bangalore, Chennai, India
1 June 9, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills

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