Centralized Clinical Trial Manager

Job Description:

Responsibilities

• 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

Qualification & Experience

• 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.