Sr Site Start-up & Regulatory Specialist (remote) South Africa

Syneos Health

South Africa
Not specified; not specified; not specified
**
Site start-up regulatory submissions
Competent authority and ec liaison
Trial master file compliance
** Syneos Health is seeking a Senior Site Start-up & Regulatory Specialist for a fully remote position in South Africa. The ideal candidate will be responsible for managing site start-up processes, ensuring compliance with local regulations, and delivering high-quality project outcomes while contributing to a collaborative and inclusive workplace culture. **

Job Summary

  • The role is responsible for quality deliverables at the country level with minimal oversight from the SSU Country Manager.
  • Candidates will act as a Subject Matter Expert for in-country performance within the Site Start-Up and clinical trial regulatory domains.
  • Syneos Health offers career development, technical training, and an inclusive culture driven by the purpose of accelerating patient progress.

Matching Summary

Match Score: 75

** Syneos Health is seeking a Senior Site Start-up & Regulatory Specialist for a fully remote position in South Africa. The ideal candidate will be responsible for managing site start-up processes, ensuring compliance with local regulations, and delivering high-quality project outcomes while contributing to a collaborative and inclusive workplace culture. **

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Site Start-Up regulatory submissions
  • Competent Authority and EC liaison
  • Trial Master File compliance
  • Country-level regulatory intelligence
  • Investigator contract negotiation

Nice-to-have

  • Subject Matter Expertise in local regulations
  • Vendor management experience
  • Mentoring junior team members
  • Continuous improvement mindset
  • Data protection guidance skills

Key Requirements

  • Experience in Clinical Research Associate or similar role
  • Knowledge of South African regulatory requirements
  • Ability to manage site activation end-to-end

Work Rights

Not specified

Tailored Resume

Cover Letter