Lead Study Start-Up Manager for Global Clinical Trials

ICON Strategic Solutions; Malaysia; On-site; MYR 120,000 - 180,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee Assistance Programme

Life assurance

Flexible benefits

Job summary

ICON Strategic Solutions in Malaysia seeks a Manager, Study Start Up to lead and oversee start-up activities for clinical trials, ensuring efficient completion and regulatory compliance. You will drive end-to-end site activation, collaborate with sponsors, operations, and regulatory colleagues, and mentor a team to achieve high performance.

You will manage cross-functional stakeholders, monitor timelines and budgets, and implement improvements to optimize the study start-up process while

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Extensive experience in clinical trial study start-up with global regulatory knowledge.
• Proven leadership in fast-paced, deadline-driven environments.
• Strong organizational and project management skills with multi-study handling.
• Excellent communication and stakeholder management with sponsors and internal teams.
• Experience with process optimization and best practices in study start-up.
• Willingness to travel approximately 25%.

Responsibilities

• Manage end-to-end study start-up processes including site identification, feasibility, regulatory submissions, and site activation.
• Lead a team of study start-up professionals with mentorship and guidance for high performance.
• Collaborate with sponsors, clinical operations, and regulatory teams to ensure regulatory compliance and timelines.
• Monitor study start-up metrics, timelines, and budgets to deliver on time and within scope.
• Identify risks in start-up and implement mitigation strategies to avoid delays.
• Drive continuous improvement in the start-up process to boost efficiency.

Skills

Leadership

Project management

Stakeholder management

Communication

Process optimization

Team mentoring

Prioritization

Travel readiness

Education

Bachelor's degree in a scientific/healthcare field

Job description

ICON Strategic Solutions in Malaysia seeks a Manager, Study Start Up to lead and oversee start-up activities for clinical trials, ensuring efficient completion and regulatory compliance. You will drive end-to-end site activation, collaborate with sponsors, operations, and regulatory colleagues, and mentor a team to achieve high performance.

You will manage cross-functional stakeholders, monitor timelines and budgets, and implement improvements to optimize the study start-up process while