About this role
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
As a Study Start-Up Manager at ICON, you will oversee and drive study start-up activities for clinical trials, ensuring all processes are completed efficiently and in compliance with regulatory requirements.
What You Will Do:
You will manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes.
Key responsibilities include:
- Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
- Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
- Build and manage strong relationships with trial investigators and stakeholders.
- Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
- Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
Your Profile:
You will be responsible for the successful execution of day-to-day site start-up and activation activities to support high-quality study delivery.
Key responsibilities include:
- Managing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation.
- Partnering closely with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation.
- Independently managing multiple studies and priorities while ensuring alignment with agreed timelines and deliverables.
- Monitoring study start-up timelines, milestones, and key metrics to ensure studies are delivered on time and within scope.
- Proactively identifying potential risks and challenges in the start-up process and implementing mitigation strategies to avoid delays or issues.
- Contributing to continuous improvement initiatives by identifying opportunities to optimize study start-up processes and enhance efficiency.
- Serving as a subject matter expert in study start-up and activation activities, providing input into best practices and process improvements.
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 local regulatory requirements and clinical operations.
- Excellent organizational and project management skills, with the ability to manage multiple studies simultaneously.
- Strong communication and stakeholder engagement skills, with the ability to collaborate effectively with sponsors and cross-functional teams.
- Experience with process optimization and applying best practices in study start-up activities.
- Ability to work independently, exercising sound judgment and accountability for deliverables.
- Willingness to travel as required (approximately 25%).
- Must be based in Hanoi
- Must be willing to work in a Hybrid setup (2-3x a week in client office)
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
About ICON plc
Global contract research organization providing outsourced clinical development services. Headquartered in Dublin, Ireland.
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