Posted:1 week ago|
Platform:
Work from Office
Full Time
Role & responsibilities To review & comment on the draft protocol, draft Informed Consent Documents (English ICD), draft Case Report Form (CRF) and/or associated documents received from (Medical Writer team) as per SOP and applicable regulatory guidelines. To review & comment on draft report including all appendices (Clinic related sections) and final e-CTD report received from Report writer in accordance with related SOP/regulatory guidelines/sponsor requirement. To review the respective documents as per defined timelines and/or as per the priority. To review the respective documents updated based on sponsor comment, regulatory observation and ensure compliance to the same. To responsible to review departmental Sops. To review Sponsor comments and regulatory observations and provide response within stipulated time line. Co-ordinate with team for implementing new sop in the system. Ensure that necessary corrective actions are taken for all the findings/comments/suggestions with appropriate preventive measures. Any other task assigned by reporting authority
Veeda CR
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