Ora

The Manager/Senior Manager will lead the Clinical Documentation team to ensure operational excellence and regulatory compliance of electronic Trial Master File (eTMF) processes. They will collaborate with cross-functional teams to maintain documentation quality, support audits, and drive continuous process improvements.

The associate is responsible for the preparation, negotiation, and management of clinical trial contracts and study budgets while ensuring regulatory compliance. They also manage the accurate and timely processing of global clinical trial site payments in accordance with contract terms and study milestones.

Responsible for researching, authoring, and editing regulatory submission materials for the FDA across clinical trial phases 1-4. The role involves coordinating with cross-functional teams to develop domestic and international drug applications and tracking regulatory milestones.