Centralized Clinical Trial Manager
Location: Bangalore or Chennai, India
Work Model: Office or Home
Job Type: Full-Time
Job Requisition ID: JR145001
Industry: Clinical Research / Clinical Operations
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Centralized Clinical Trial Manager to join our dynamic team in India. This is a critical role for ensuring the quality, accuracy, and compliance of site visit reports while supporting clinical trial operations across multiple studies.
Role Overview
As a Centralized Clinical Trial Manager, you will act as an extension of the CTM/CTM team, responsible for reviewing and approving site visit reports in line with Protocols, ICON SOPs, and Sponsor guidelines. You will ensure timely follow-up on action items, protocol deviations, and safety trends, serving as a liaison between Clinical Research Associates (CRAs), CTMs, and Project Managers (PMs) to maintain high standards in clinical trial delivery and patient safety.
Key Responsibilities
Review and approve site visit reports to ensure quality, accuracy, and compliance with Protocol, ICON SOPs, and Sponsor requirements.
Follow up on action items, protocol deviations, and safety trends; escalate issues as necessary to maintain study integrity.
Collaborate with CRAs, CTMs, and PMs for timely resolution of site-related issues.
Monitor operational metrics including MVR/FUL timelines, open action items, and protocol deviations, ensuring adherence to contract and corporate standards.
Attend project meetings and provide recommendations to improve the quality of site visit reports and operational efficiency.
Support continuous improvement initiatives within clinical trial processes to optimize performance and reduce errors.
Ensure adherence to ICH GCP guidelines, relevant regulatory requirements, and internal SOPs.
Train and mentor team members to enhance performance and maintain compliance.
Maintain effective communication with stakeholders and support cross-functional collaboration across studies.
Travel as required to support study oversight and process improvement activities.
Candidate Profile
Bachelor’s degree in Life Sciences, Healthcare, or a related field; advanced degree preferred.
8–10 years of clinical research experience with at least 5 years in on-site monitoring or clinical trial management.
Strong expertise in on-site monitoring approaches, clinical trial operations, and report review processes.
Proficiency in clinical trial data analysis, interpretation, and regulatory compliance.
Excellent organizational, project management, and multitasking abilities.
Strong analytical, communication, and interpersonal skills with the ability to collaborate across teams.
Fluency in written and spoken English; computer literate.
Experience Required
Minimum 8 years of clinical research experience.
At least 5 years of on-site monitoring or centralized clinical trial management experience.
Demonstrated experience in reviewing, analyzing, and approving site visit reports for multiple studies.
What ICON Offers
Competitive salary and global career growth opportunities.
Comprehensive benefits including health insurance, retirement planning, life assurance, and wellness programs.
Flexible work options and a supportive, inclusive work culture.
Training and professional development opportunities to enhance skills and career progression.
Access to global networks and tools for knowledge sharing and continuous learning.
ICON is committed to equal employment opportunities and fostering an inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, disability, or other protected status.
This is a strategic opportunity for experienced clinical research professionals seeking a pivotal role in centralized clinical trial oversight. Apply now to advance your career with ICON.
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