Senior Study Start Up Associate

ICON · Bucharest, Romania

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Clinical OperationsFull-timeCompany career page

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What they're looking for

Bachelor's degree in life sciences or related field
Minimum 2 years clinical research or regulatory affairs experience
Study start-up and site activation experience
Strong knowledge of ICH-GCP and local regulatory requirements
Project management skills with ability to handle multiple priorities
Cross-functional collaboration and communication abilities
Willingness to travel approximately 5%

What you'll be doing

Lead preparation and submission of regulatory documents and clinical trial applications
Coordinate with internal and external stakeholders to obtain study initiation approvals
Maintain accurate records of regulatory submissions, approvals, and correspondence
Provide guidance to study teams on regulatory requirements and start-up best practices
Participate in process improvement initiatives to enhance start-up efficiency

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