Clinical Operations Manager
1 week ago
Parexel is currently seeking an experienced Clinical Operations professional to join us, you 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
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