Study Start-Up Lead (Remote)

Job summary

This role involves leading and empowering site activation teams across multiple countries to ensure the successful planning and activation of clinical trials. The position focuses on improving study start-up metrics and implementing optimized processes in collaboration with Clinical Operations.

Qualifications

• Bachelor’s degree in Life Sciences or equivalent.
• Over 4 years of experience in clinical operations, project management, site start-up, or trial optimization.
• At least 2 years of direct management experience in site activation and study start-up processes within a sponsor or CRO.
• Proven experience in creating country-specific Informed Consent Forms (ICFs).
• Strong proficiency with data models, forecasting tools, and database structures.
• Experience in global site start-up environments is preferred.
• Ability to clearly explain complex data and support data-driven decision-making.
• Expert understanding of successful study start-up and site selection strategies.
• Fluency in local language and English.

Responsibilities

• Lead and mentor the FSP Site Start-Up team supporting global clinical programs.
• Develop and refine data-driven forecasting models and planning scenarios.
• Ensure consistent application of SSU standards across projects and support ongoing process improvements.
• Drive the delivery of “Ready to Enroll” status for both sponsor and CRO-supported sites.
• Serve as the escalation point for site activation challenges, collaborating with Study Managers to resolve issues.

Skills

• Strong leadership and mentoring abilities.
• Excellent analytical and problem-solving skills.
• Proficient in using leading industry data sources and tools for forecasting and site readiness insights.

Education

• Bachelor’s degree in Life Sciences or equivalent.

Tools

• Familiarity with data models and forecasting tools.