Clinical Operations Manager - Regulatory and Ethics - Johannesburg

Parexel is currently seeking an experienced Clinical Operations professional to join us, you will be assigned to one of our key sponsors in the region.

Working as a Clinical Operations Manager, specifically for Regulatory and Ethics, you’ll be responsible for overseeing regulatory and ethics submissions for assigned studies across South Africa, Kenya, and Uganda.

Some specifics about this advertised role:

• 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.

Here are a few requirements specific to this advertised role:

• 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.