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Clinical Operations Lead (Clinical Trial Manager) (Africa)

3 weeks, 1 day ago
South Africa
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 32

Description

  • Oversee regional CRAs and investigator sites to ensure compliance with study protocol, study plans, GCP, ICH guidelines, local regulations, and timelines.
  • Provide monitoring support and co-monitoring visits to help sites and CRAs meet performance and compliance standards.
  • Act as the primary liaison between regional CRAs and the clinical project team, including sponsor-facing communication and status updates.
  • Lead project-specific CRA training, mentoring, and assessment visits, and ensure study training requirements are completed and documented.
  • Prepare, implement, and maintain monitoring plans, study tools, training materials, and other structural project documentation.
  • Review visit reports, track protocol deviations, and monitor site management quality, compliance, and follow-up actions.
  • Support enrollment and recruitment strategy development and implementation with the clinical project team.
  • Oversee regional startup and feasibility activities and assist with vendor management as needed.
  • Manage site, country, and monitoring performance metrics, including escalation of issues and corrective actions.
  • Support financial project management activities such as revenue recognition, site payments, and pass-through expense review.

Requirements

  • College diploma/degree with 7-9 years of related experience and continuous training, or an undergraduate degree with 4-6 years of experience and substantial ongoing job-related training.
  • Minimum of 3 years of CRA experience.
  • Health Sciences, Life Sciences, or Nursing background preferred.
  • SoCRA and/or ACRP certification or designation preferred.
  • 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, and highly organized.
  • Strong understanding of GCPs, local regulations, IRB/EC requirements, and investigator responsibilities.
  • Demonstrated ability in report writing and in critically understanding clinical research documents.
  • Ability to manage multiple tasks and meet deadlines in a dynamic environment.

Benefits

  • Home-based work arrangement.
  • Accommodations for persons with disabilities are available on request.
  • Employer communication uses verified Alimentiv email addresses to help protect candidates from phishing scams.

Interested in this position?

Apply directly on the company website

Apply Now

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