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2 - 5 years
4.0 - 7.0 Lacs P.A.
Hyderabad
Posted:2 months ago| Platform: 
Work from Office
Full Time
The Clinical Trial Disclosure Senior Specialist will provide the operational support of: Redaction of clinical trial documents in accordance with evolving global regulations. Manage and coordinate projects related to the redaction of clinical documents in accordance with EU Clinical Trial Regulation (EUCTR), EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), FDAAA Final rule and other global regulations. Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements. Perform quality control of redacted documents. Manage and track redaction book of work, compile and report on volume and performance metrics. Provide operational support to CT Results Managers, as required
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