Study Start Up Lead

• Lead and oversee study start-up activities across assigned projects from award to site activation
• Develop and maintain start-up plans, timelines, and project milestones
• Partner with Project Managers to identify risks and implement mitigation strategies
• Coordinate Ethics Committee (EC/IRB) submissions and collaborate with Regulatory teams on Health Authority requirements
• Support site feasibility, site activation, and greenlight processes
• Coordinate clinical trial agreement negotiations alongside Legal and operational teams
• Ensure study documentation is complete, accurate, and submitted to the Trial Master File
• Monitor start-up metrics and provide regular progress updates to project stakeholders
• Support continuous improvement initiatives, SOP development, and operational best practices
• Contribute to bid defenses, proposals, and business development activities when required

• Bachelor's degree in Life Sciences, Nursing, or a related field
• Minimum 4 years of clinical research experience with a strong focus on study start-up activities
• Good understanding of ICH-GCP guidelines and regulatory requirements
• Experience coordinating multiple projects in a fast-paced environment
• Strong organizational, planning, and problem-solving skills
• Excellent written and verbal communication skills in English
• Experience in submissions in the US and Australia is good to have

• Competitive compensation package
• Comprehensive benefits
• Opportunity for personal and professional growth
• Collaborative and innovative work environment