[Hiring] Centralized Clinical Trial Manager @ICON plc

Role Description

As a Centralized Clinical Trial Manager at ICON, you will play a crucial role in effectively reviewing site visit reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards, errors are minimized and that issues are escalated as appropriate. You will be responsible for follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues. You will act as an extension of the CTM/CTM team for the specific purpose of visit report review and approval.

Location: Bangalore or Chennai (Home Based or Office Based)

• Effectively review visit reports as per Protocol and ICON and Sponsor SOPs.
• Follow up on action items and protocol deviations.
• Act as a liaison between CRA, CTM, and PM for timely resolution of issues.
• Observe and escalate safety trends in patients as identified in visit reports.
• Recognize, exemplify, and adhere to ICON's values centered around People, Clients, and Performance.
• Create a culture of process improvement focused on streamlining processes and meeting client needs.
• Review and approve visit reports ensuring consistency and adherence to quality standards.
• Ensure turnaround time of the visit reports per contract, ICON, and/or Sponsor SOPs.
• Regular oversight of OMR, ICO trial, and other systems to ensure key metrics are met.
• Attend project meetings and provide suggestions for improvement of report quality.
• Liaise with CTM to communicate trends, outstanding issues, and safety concerns.
• Ensure all necessary trainings are completed to improve job performance.
• Thorough knowledge of ICH GCP and relevant regulations for clinical trials.
• Fluent in written and spoken English.
• Computer literate.
• Ability and willingness to travel if required.
• Extensive use of telephone expected for continuous improvement in trial processes.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or a related field (advanced degree preferred).
• Minimum 8-10 years of Clinical Research experience with at least 5 years of on-site monitoring experience.
• Experience in On-Site Monitoring and Clinical Trial Management.
• Strong analytical skills with proficiency in clinical trial data review and interpretation.
• Excellent organizational and project management skills.
• Effective communication and interpersonal skills.

Requirements

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.

Company Description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients, and suppliers.