Centralized Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Centralized Clinical Trial Manager to join our diverse and dynamic team. 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)

What You Will Be Doing:

• To effectively review 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
• To follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues.
• To act as an extension of the CTM/CTM team for the specific purpose of visit report review and approval.
• To observe and escalate safety trends in patients as identified in visit report
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance .
• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Effectively review and approve visit reports as per annotated report, protocol, ICON and/or Sponsor SOPs and ensure errors are minimized , reports are consistent across visits and sites and adhere to the highest standards of quality . Ensure turnaround time of the visit reports per contract, ICON and or Sponsor SOPs
• Regular oversight of OMR , ICO trial (and where required Sponsor CTMS and vendor systems) to ensure key metrics, e.g. MVR and FUL timelines, Action Items and other quality metrics are being met and followed-up as necessary Ensure open action items and protocol deviations are escalated and followed up for timely resolution as per contract or corporate standards .
• Where required , attend project meetings and actively provide suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends .
• Liaise with CTM to communicate any trends , outstanding issues, safety concerns or any other activity or lack thereof which may jeopardise the clinical trial delivery or patient safety .
• Ensure all necessary trainings , required to improve job performance managing people and project or process related issues which are necessary to perform successfully in a service oriented environment.
• Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials. . Fluent in written and spoken English.
• Computer literate.
• Ability and willingness to travel if required
• Extensive use of telephone expected continuous improvement in trial processes.

Your Profile:

• 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, with a solid understanding of on-site monitoring approaches.
• Strong analytical skills with proficiency in clinical trial data review and interpretation.
• Excellent organizational and project management skills, with the ability to manage multiple studies and meet deadlines.
• Effective communication and interpersonal skills, with the ability to collaborate across diverse teams and functions.

What ICON can offer you:

Visit our to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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