Risk Management à United States

Lead pivotal vaccine trials across diverse Southeast Asian markets. You'll ensure regional study delivery from initiation to close‑out, collaborating with cross‑functional teams to advance the portfolio in infectious diseases.

• End-to-End Project Leadership: Manage regional operational strategy, timelines, budgets, and risk mitigation for Phase II‑IV vaccine trials across SEA (Singapore, Malaysia, Thailand, Indonesia, Vietnam, Philippines)
• Site Excellence: Oversee site selection, initiation, monitoring, and close‑out activities, ensuring compliance with ICH‑GCP and local regulations
• Vendor Partnership: Lead CROs, central labs, and regional vendors to deliver quality data on schedule
• Stakeholder Engagement: Serve as primary point of contact for investigators, internal teams (Medical, Regulatory, Data Management), and country managers
• Risk Management: Proactively identify and resolve operational challenges across diverse regulatory environments
• Resource Stewardship: Manage regional budgets and mentor junior CRAs

• Experience: 5+ years in clinical operations with 2+ years’ direct project management experience leading multi‑country multi‑site trials
• Therapeutic Expertise: Demonstrated clinical trial experience Phase I‑III, experience in vaccine trials
• Regional Knowledge: Proven success managing studies in Southeast Asia; familiarity with country‑specific regulatory landscapes
• Technical Skills: Mastery of ICH‑GCP, clinical trial management systems (CTMS), and risk‑based monitoring
• Education: Bachelor’s degree in Life Sciences (Advanced degree preferred)

Interested applicants please include a summary table about your different clinical trial projects, including the TA, indication & Phase, your role & involvement, country coverage, study sample / size.

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