About the Role
This role is responsible for maintaining and updating clinical trial information within the Clinical Trial Information System, ensuring data accuracy, compliance with regulations, and timely submissions to health authorities.
Responsibilities
- Manage data input and updates in the Clinical Trial Information System (CTIS)
- Ensure all clinical trial documentation meets regulatory requirements
- Support timely publication of trial data in compliance with EU CTR guidelines
- Collaborate with cross-functional teams to gather necessary trial information
- Monitor CTIS dashboards for pending actions and deadlines
- Verify completeness and accuracy of trial records before submission
- Respond to queries from internal teams regarding CTIS processes
- Track and report on CTIS submission statuses
- Assist in resolving system-related issues with IT support
- Maintain up-to-date knowledge of evolving regulatory standards
- Coordinate with project managers to align CTIS timelines
- Prepare documentation for audit readiness
- Support training initiatives for new CTIS users
- Follow standard operating procedures for data governance
- Escalate critical issues to senior management when required
- Participate in system validation and testing activities
- Ensure data privacy and security protocols are followed
- Assist in onboarding new studies into the system
- Maintain logs for all CTIS-related activities
- Provide status updates during team meetings
- Work closely with regulatory affairs specialists
- Update trial records in response to protocol amendments
- Ensure alignment with global clinical operations
- Support inspection readiness efforts
- Adhere to company quality standards
Compensation
Competitive salary commensurate with experience
Work Arrangement
Hybrid work model with remote and office components
Team
Part of the Global Clinical Operations team supporting regulatory compliance
About the Team
- This position operates within a global clinical operations unit focused on regulatory compliance and trial transparency.
- Team members collaborate across time zones to ensure timely and accurate trial submissions.
Technology Environment
- Primary tools include the Clinical Trial Information System (CTIS), Microsoft 365, and internal compliance platforms.
- Regular access to secure databases and regulatory portals is required.
Not available for this position
