Description
As a Senior Study Start Up Associate at ICON Strategic Solutions in Malaysia, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
You will lead and oversee the start-up activities for clinical trials, ensuring that all processes are completed efficiently and in compliance with regulatory requirements.
Key Responsibilities:
- Manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes.
- 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 implement strategies to mitigate delays.
- Drive continuous improvement initiatives to optimize the study start-up process.
Requirements:
- Bachelor's degree in a relevant scientific discipline or healthcare-related field.
- Extensive experience in clinical trial study start-up.
- Proven leadership skills.
- Excellent organizational and project management skills.
- Strong communication and stakeholder management skills.
- Experience with process optimization and implementing best practices.
- Willingness to travel approximately 25%.
Rewards & Benefits:
- Competitive base salary and performance-related incentives.
- Health and wellbeing programmes.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programmes and wellbeing resources.
- Learning and development opportunities.