Responsibilities
- Validate and maintain the electronic data capture (EDC) system, including updates to supporting documentation such as eCRF design specifications, edit check documents, UAT test logs, issue logs, and summary reports.
- Support oversight of user access for the EDC and other clinical databases, including maintaining master user lists and verifying proper activation and deactivation of accounts.
- Ensure timely and thorough review of clinical study data listings for completeness and accuracy.
- Lead or conduct reconciliation of critical data points in the EDC against external sources, including safety databases and third-party data providers.
- Assist in designing and testing core clinical data management components such as electronic case report forms, edit checks, reports, and data listings.
- Manage communication of data discrepancies to investigative sites through structured query processes.
- Escalate critical data issues to the lead data manager and relevant study team members to enable prompt resolution.
- Apply professional judgment and prior experience to investigate data challenges, evaluate solutions, and propose alternative approaches independently.
- Demonstrate prior experience leading data management activities at the study level and coordinating with external service providers.
Compensation
Desired salary or hourly rate is requested during application.
Work Arrangement
Remote with potential for hybrid work model; relocation and travel expectations are assessed during hiring.
Team
Client-facing position requiring direct interaction with sponsors and cross-functional teams.
Team
This is a client-facing role requiring direct engagement with sponsors and study teams.
Applicants must disclose current or future sponsorship needs for employment authorization.
