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Study Start-Up Manager, Malaysia (Remote)
Lead clinical trial site start-up and activation for ICON plc in Malaysia. Manage study start-up teams, regulatory submissions, timelines, budgets, and process improvements.
विवरण
- Oversee daily site start-up and activation work.
- Coordinate the full study start-up cycle, from site selection and feasibility through regulatory submissions and activation.
- Guide and mentor a team of study start-up professionals.
- Work with sponsors, clinical operations, and regulatory teams to meet local and global requirements and timelines.
- Track start-up performance, schedules, and budgets.
- Assess start-up risks and put mitigation plans in place.
- Improve study start-up processes to increase efficiency.
आवश्यकताएँ
- Hold a bachelor’s degree in a relevant science or healthcare field.
- Bring substantial experience in clinical trial start-up, with strong knowledge of global regulatory requirements and clinical operations.
- Have a track record of leading and mentoring teams in fast-paced, deadline-focused settings.
- Demonstrate strong organization and project management skills, including the ability to oversee multiple studies and competing priorities.
- Communicate effectively and manage relationships with sponsors and internal stakeholders.
- Have experience improving processes and applying best practices to study start-up work.
- Be willing to travel as needed, approximately 25%.
- Have legal authorization to work in Malaysia.
लाभ
- Competitive base pay with performance-related incentives.
- Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programs and wellbeing resources.
- Structured training and career pathways for learning and development.
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