Parexel
Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions
10,000+
💰 Venture Round on 1990-01
Clinical Operations Manager - Regulatory
September 15
Parexel
Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions
10,000+
💰 Venture Round on 1990-01
Description
• Clinical Operations Manager (Regulatory) accounts for performance and compliance with assigned protocols, ensuring adherence to ICH/GCP, country regulations, and quality standards. • Collaborates to manage compliance with regulatory processes and submissions.
Requirements
• Extensive experience in local EC and RA submission (must be familiar with XML completion) – including initial submission and protocol amendments submission. • Experience in Independently preparing submissions (CTC supports with documents collection) to both EC and RA. • Experience in ICF preparation using templates. • Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups. • Experience in IMP supplies management at the local level (vendors providing background meds, the standard of care, etc.) • Experience in validation of translated documents.
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