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

Syneos Health

South Africa
Remote
Country level quality deliverables
Forecast submission/approval timelines
Track milestone progress
Responsible for quality deliverables at the country level, with minimal oversight, forecasting submission/approval timelines, and ensuring compliance

Job Summary

  • Responsible for quality deliverables at the country level, with minimal oversight, forecasting submission/approval timelines, and ensuring compliance.
  • May be involved in various functions including Local Submissions Specialist, Country Start-Up Advisor, Local Site ID and Feasibility Support, and Local Investigator Contract and Budget Negotiator.
  • Responsible for operational delivery across the country portfolio, analyzing metrics to ensure project deliverables are met and increasing efficiency in overall project delivery.

Matching Summary

Responsible for quality deliverables at the country level, with minimal oversight, forecasting submission/approval timelines, and ensuring compliance.

Skills & Requirements

Must-have

  • country level quality deliverables
  • forecast submission/approval timelines
  • track milestone progress
  • analyze data for delays
  • provide contingency plans
  • monitor financial aspects
  • ensure TMF compliance
  • continuous improvement of SSU quality
  • local submissions
  • essential document collection
  • regulatory authority submissions
  • oversee ongoing submissions
  • liaison between sites and functional leads
  • site activation end to end process
  • in-country regulatory intelligence
  • data protection guidance
  • site selection support
  • contract and budget negotiation
  • quality control of CTAs
  • operational delivery across country portfolio
  • analyze country and site metrics

Nice-to-have

  • passionate problem solvers
  • agile and driven to deliver
  • career development and progression
  • inclusive culture
  • authentically be yourself
  • shape the future of healthcare
  • challenge the status quo
  • highly competitive environment

Key Requirements

  • minimal oversight from SSU Country Manager
  • minimal oversight from the SSU Country Manager
  • minimal oversight from the SSU Country Manager

Work Rights

Not specified

Tailored Resume

Cover Letter