Clinical Operations Manager - Regulatory And Ethics - Johannesburg

When our values align, there's no limit to what we can achieve.
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 roleDedicated 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?translationsInteractions?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