Study Start Up Associate II
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Job Description
Study Start Up Associate II leading regulatory submissions and site activation for ICON’s global clinical research organization. Coordinating approvals and supporting compliant clinical trial initiation across Taiwan, Malaysia, and Korea.
Responsibilities:
- Lead the initiation of clinical trials, ensuring compliance with regulatory requirements
- Contribute to site start-up and activation activities, taking responsibility for deliverables and working collaboratively
- Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
- Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
- Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence
- Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities
- Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency
Requirements:
- 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%)
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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