Study Start up Associate II
ICON · Lund, Sweden +1 more
Clinical OperationsFull-timeCompany career page
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Role summary
ICON seeks a Study Start Up Associate II to lead clinical trial initiation activities in Lund or Copenhagen. The role focuses on regulatory document preparation, stakeholder coordination, and compliance management while supporting study teams through the start-up process.
What they're looking for
- Bachelor's degree in life sciences or related field
- Minimum 2 years clinical research or regulatory affairs experience with study start-up focus
- Strong knowledge of ICH-GCP and local regulatory requirements for clinical trials
- Excellent project management and multitasking abilities
- Strong communication and cross-functional collaboration skills
- Willingness to travel approximately 5%
- Legal right to work in Sweden or Denmark
What you'll be doing
- Lead preparation and submission of regulatory documents including trial applications and ethics submissions
- Coordinate with internal and external stakeholders to obtain study initiation approvals
- Maintain comprehensive records of submissions, approvals, and regulatory correspondence
- Guide study teams on regulatory requirements and start-up best practices
- Contribute to process improvement initiatives for study start-up efficiency
Privacy & handoff
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