Remote Global Study Start-Up Strategy Lead

Jazz Pharmaceuticals

Palo Alto (CA)

On-site

USD 165,000 - 247,000

Full time

10 days ago
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Job summary

Jazz Pharmaceuticals in the United States seeks an Associate Director, Study Start Up Strategy, to provide advanced expertise in global CTSU processes and lead cross-functional start-up efforts across trials. You will oversee country/site activation plans, leverage analytics and predictive data to optimize timelines, manage CROs, and drive continuous improvement while ensuring regulatory compliance.

The role requires 8–10 years in clinical research with 5+ years in start-up, a life sciences

Qualifications

  • Bachelor's degree in life sciences or related field; advanced degree preferred.
  • 8–10 years in clinical research with 5+ years focused on start-up or site activation.
  • Strong understanding of global regulatory requirements and IRB/EC processes.
  • Experience leading cross-functional teams and managing CROs/vendors.
  • Proficiency with SSU tools and assessment of new technologies (AI) in SSU space).

Responsibilities

  • Lead or oversee development and execution of study-level start-up strategies and country/site activation plans.
  • Develop site activation projections and input into study timelines from data-driven assessments.
  • Serve as SME on global start-up pathways and guide internal teams and partners.
  • Partner cross-functionally to align start-up activities with protocol requirements and governance.
  • Oversee CROs/vendors and track KPIs, timelines, and risk management.
  • Lead initiatives to improve start-up methodology, tools, and processes.
  • Support audit readiness and regulatory submissions documentation.
  • Represent SSU in industry discussions and governance meetings.

Skills

SSU expertise
Cross-functional leadership
Data-driven insights
CTMS experience
Veeva Vault
Regulatory knowledge
Leadership

Education

Bachelor's degree in life sciences
Advanced degree preferred

Tools

CTMS
Veeva Vault
Document management

Job description

Jazz Pharmaceuticals in the United States seeks an Associate Director, Study Start Up Strategy, to provide advanced expertise in global CTSU processes and lead cross-functional start-up efforts across trials. You will oversee country/site activation plans, leverage analytics and predictive data to optimize timelines, manage CROs, and drive continuous improvement while ensuring regulatory compliance.

The role requires 8–10 years in clinical research with 5+ years in start-up, a life sciences

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