Clinical Operations Manager - Regulatory and Ethics

3 days ago

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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

• Responsible for overseeing regulatory and ethics submissions for assigned studies across South Africa, Kenya and Uganda • Dedicated to one client • Executes and oversees clinical trial country submissions and approvals for assigned protocols including: • Development of local language materials including local language Informed Consents and translations • Interactions with IRB/IEC and Regulatory Authority for assigned protocols

Requirements

• Bachelor's degree in business finance/ administration/ Life Science or equivalent • Health Care related experience required • 5‐7 years clinical research or combined experience in Clinical Research and Finance/Business required • Expertise of core clinical systems, tools, and metrics • Excellent verbal and written influencing and training/mentoring skills, in local language and English • Strong coordination and organizational skills • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up