eCOA Review Specialist
hace 2 meses
Job Overview
IQVIA is seeking a meticulous and detail-oriented eCOA Review Specialist to join our team, focusing on the review and validation of screens used in electronic Clinical Outcomes Assessment (eCOA) implementation.
Key Responsibilities
Conduct thorough reviews of eCOA screens to ensure accuracy, functionality, and compliance with study protocols and regulatory standards.
Verify the correctness of translated content on eCOA screens, ensuring linguistic accuracy and cultural appropriateness.
Test the functionality of eCOA screens, including navigation, data capture, and response logic, to ensure they work as intended.
Implement quality assurance procedures to identify and rectify any issues related to screen content, layout, and functionality.
Collaborate with project managers, linguists, developers, and other stakeholders to address and resolve any discrepancies or issues found during the review process.
Document review findings, test results, and any changes made to eCOA screens, maintaining thorough and accurate records.
Ensure that all screen review activities comply with relevant regulatory requirements and industry standards for clinical research and eCOA implementation.
Manage multiple, parallel projects simultaneously.
Follow company and department standard operating procedures.
Assist with the establishment of new procedures and offer suggestions for process improvements for existing procedures.
Required Skills and Qualifications
High school diploma or equivalent.
Bachelor's degree preferred.
Excellent written/verbal communication skills.
Fluency in English is essential, an additional language would be a strong asset.
Previous experience in project management of localization and/or quality assurance work is a bonus.
Meticulous attention to detail to ensure accuracy and consistency in translated content and project documentation.
Ability to follow instructions/guidelines, work independently and on own initiative.
Ability to establish and maintain effective working relationships with co-workers, managers and clients with demonstrated cultural and emotional intelligence.
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