Clinical Operations Manager - Regulatory

September 15

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 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.