Clinical Trial Manager overseeing clinical studies with a focus on Atopic Dermatitis. Ensuring compliance with ICH GCP and delivering results within contractual timelines.
About the role
- Centralized Clinical Trial Manager at ICON responsible for reviewing clinical trial site visit reports and ensuring quality standards. Act as a liaison for timely resolution of issues.
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
- 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.
Requirements
- 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.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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