Site Activation Lead – Trials & Regulatory Submissions

Syneos Health

Argentina

On-site

ARS 106,110,000 - 166,745,000

Full time

9 days ago

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Job summary

Syneos Health is seeking a Site Activation Specialist with US experience to manage country-level start-up activities, including regulatory submissions, site activation, and essential document handling. You will coordinate with country leads and external authorities to ensure compliant, timely start-ups for clinical studies.

You will oversee submission milestones, maintain TMF readiness, and collaborate with SAM/PM to optimize site activation processes across trials.

Responsibilities

  • General – Responsible for providing quality on deliverables at the country level with oversight from the SSU Country Manager.
  • Follows forecasted submission/approval timelines, tracks milestones in SSU system, and escalates delays.
  • Monitors basic financial aspects of the project and hours/tasks per contract; escalates discrepancies.
  • Reviews SOPs and WIs, keeps training records updated and ensures timesheet compliance.
  • Ensure all relevant documents are submitted to the Trial Master File per SOP/Sponsor requirements.
  • Oversee site activation end to end at country/site level.
  • Support Local Submissions, EC/RA Applications, and local regulatory submissions.
  • May assist in site contracts, budgets, and archiving documents.
  • May liaise between investigational sites and leads; coordinate with SAM/PM.

Job description

Syneos Health is seeking a Site Activation Specialist with US experience to manage country-level start-up activities, including regulatory submissions, site activation, and essential document handling. You will coordinate with country leads and external authorities to ensure compliant, timely start-ups for clinical studies.

You will oversee submission milestones, maintain TMF readiness, and collaborate with SAM/PM to optimize site activation processes across trials.

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