Manager, Study Start Up

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

SSU Manager in Malaysia

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Manager, Study Start Up at ICON, 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.

What You Will Do

You will manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes.

Key Responsibilities Include

• Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation.
• Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery.
• Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation.
• Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope.
• Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues.
• Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency.

Your Profile

You will have solid site start-up and activation experience, with the ability to manage competing priorities and develop your team.

Required Qualifications And Experience

• 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%)

What ICON Can Offer You

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here