Clinical Study Start-Up Specialist II

ICON Strategic Solutions; Malaysia; On-site; MYR 90,000 - 120,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory knowledge

Project management

Communication

Collaboration

Travel readiness

Education

Bachelor's degree in life sciences

Job description

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.