Clinical Operations Lead (Clinical Trial Manager) (Africa)
On-siteJohannesburg, Gauteng, South Africa
Job Summary
Oversee clinical operations for a regional/global project, including CRAs, Investigator sites, and monitoring plans. Conduct assessment visits, develop study tools, and implement enrollment strategies while ensuring compliance with ICH-GCP and local regulations. Provide training to CRAs, review visit reports, and manage site performance metrics. Liaise with the clinical project team, Study Sponsor, and vendors to drive project deliverables and escalate issues. Manage regional startup activities and contribute to financial project management processes. Perform global and individual CRA calls, attend Sponsor meetings, and present at Kickoff and Site Qualification visits. Work remotely with a minimum of 7-9 years of related experience.
Required Qualifications
- College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
- Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training
- Health Sciences, Life Sciences or Nursing specialty
- SoCRA and/or ACRP Certification/Designation
- Minimum of 3 years CRA experience
- Strong experience with EDC systems
- Proficiency with MS Office
- Strong written and verbal communication skills
- Highly effective interpersonal and organizational skills
- Proactive
- Detail oriented
- Task-driven
- Highly organized
- Critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities
- Demonstrated ability in report writing
- Strong ability to critically understand clinical research documents
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
Desired Qualifications
- Health Sciences, Life Sciences or Nursing specialty preferred
- SoCRA and/or ACRP Certification/Designation
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