Clinical Operations Manager (FSP) at PAREXEL

Hybrid home/office-based Johannesburg.

The Clinical Operations Manager (COM) is accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

The Experience Required Is Listed Below

• Has been involved study from country selection to close-out visits
• Supported all aspects of the study outside of submissions
• Experience in ICF adaptations for study and site
• Annual re-approvals to RA and CEC/LEC
• Submissions for import and export licenses
• Master Trial Agreements adaptations for study and sites
• Extensive involvement in study start-up
• Involvement in the ordering of study/site supplies and distribution (Equipment, labs, e.g.)
• Involvement in ordering and management of IMP distribution

We offer exceptional financial rewards, training, and development. Expect exciting professional challenges, but with a healthy work/life balance. We value your welfare just as highly as that of our patients.