eCOA Review Specialist
hace 6 días
Job Overview
IQVIA is seeking a detail-oriented eCOA Review Specialist to focus on the review and validation of eCOA screens used in electronic Clinical Outcomes Assessment implementation.
The ideal candidate will possess a keen eye for detail and excellent analytical and problem-solving skills.
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.
- Assist with the establishment of new procedures and offer suggestions for process improvements for existing procedures.
- Contribute to the continuous improvement of processes and develop relevant guidance documents.
Required Skills and Qualifications
- High school diploma or equivalent.
- Bachelor's degree preferred.
- Excellent written and 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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