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 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.
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
- 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
- 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
Rewards & 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