Regulatory Technician
ICON plc
full-time
Posted on:
Location Type: Office
Location: Mexico City • Mexico
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Tech Stack
About the role
- Work with the Clinical Trials Information System (CTIS)
- Provide support for submissions and other documents by performing necessary tasks including assembly, dispatch among others and coordinating resources for submissions.
- Proactively identify and mitigate risks through CTIS helpdesks regarding data/document management and upload to CTIS and liaise with internal/external stakeholders to resolve
- Actively maintain applicable study-level account access for assigned projects for CTIS to maintain compliance and confidentiality
- Collaborate with key stakeholders to manage and perform data entry and document upload
- Monitor CTIS notifying applicable stakeholders of activities for their action and subsequent follow up
- Create files documenting submissions completed through CTIS, conclusions, decisions and any other communication provided via CTIS
- Perform Quality Control review in accordance with applicable process
- Maintain agreed timelines
- Ensure project-specific training is completed on time, as applicable
Requirements
- Minimum 3 years of relevant experience within clinical research and have knowledge of clinical terminology and documentation
- Advanced expertise of applicable Clinical Trial Regulatory system/portal
- Mandatory advanced English (speak, read, write)
- Ability to work independently
- Experience with regulatory submissions and CTIS is a differential but not mandatory
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data entrydocument managementQuality Control reviewregulatory submissionsclinical terminologyclinical research
Soft Skills
independent workstakeholder collaborationrisk identificationcommunication