Manager, Study Start Up

• Manage day-to-day site start-up and activation activities
• Manage and oversee the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation
• Lead a team of study start-up professionals, providing guidance, mentorship, and support
• Collaborate with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines
• Monitor study start-up metrics, timelines, and budgets
• Identify potential risks and challenges and implement mitigation strategies
• Drive continuous improvement initiatives to optimize study start-up and enhance efficiency

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations
• Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment
• Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously
• Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams
• Experience with process optimization and implementing best practices in study start-up activities
• Willingness to travel as required (approximately 25%)
• Legal right to work in Malaysia

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways