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Submission Expert in Clinical Trials
1 week ago
Clinical Trial Submission Role
We are looking for an accomplished Clinical Trial Submission Manager to lead the submission of initial Clinical Trial Applications (CTAs) and amendments to Health Authorities (HAs) and Ethics Committees (ECs). As part of our dynamic CTA Management department, you will work closely with various stakeholders across Development and Affiliate to ensure timely and compliant submissions on a global scale.
- Develop and implement efficient CTA submission processes to meet business needs and priorities.
- Ensure CTA submission adheres to all applicable regulatory requirements worldwide, driving consistency and best practices across trials.
- Oversee the preparation and monitoring of CTA documents for submission of initial CTAs and amendments.
- Support the team in analyzing and resolving CTA-related issues.
- Contribute to CTA process and system improvements to enhance efficiency and effectiveness.
Key Responsibilities
- Develop and maintain strong relationships with cross-functional teams and stakeholders.
- Analyze and resolve complex CTA-related issues.
- Collaborate with colleagues to improve CTA processes and systems.
