Study Start Up Associate II

ICON Strategic Solutions; Malaysia; Sur place; MYR 90 000 - 120 000; Plein temps

Résumé du poste

ICON Strategic Solutions is seeking a Study Start Up Associate II in Malaysia to lead study initiation, ensure regulatory compliance, and support cross-functional teams. The role emphasizes preparing regulatory submissions, coordinating approvals, and maintaining precise records to drive efficient study activation.

Ideal candidates have a life sciences background, 2+ years in clinical research or regulatory affairs, and strong organizational and communication skills.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Minimum of 2 years of experience in clinical research or regulatory affairs.
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulations.
• Excellent organizational and project management skills with ability to multitask.

Responsabilités

• Lead preparation and submission of regulatory documents and ethics approvals.
• Coordinate with internal and external stakeholders to obtain approvals for study initiation.
• Maintain comprehensive records of regulatory submissions, approvals and correspondence.
• Provide guidance on regulatory requirements and best practices for study start-up activities.
• Participate in process improvements to streamline start-up processes.

Connaissances

Regulatory knowledge

Project management

Communication

Collaboration

Travel readiness

Formation

Bachelor's degree in life sciences

Description du poste

SSUA II

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 Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

What You Will Do

You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.

Key Responsibilities Include

• Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
• Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your Profile

You will bring relevant site start-up and activation experience, along with the following qualifications and skills.

Required Qualifications And Experience

• Bachelor's degree in life sciences or a related field.
• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
• Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Willingness to travel as required (approximately 5%)

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.

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