Study Start Up Associate II / Submission Specialist / Study Start Up Lead

About the Role ICON is a world-leading healthcare intelligence and clinical research organization. We’re looking for a Study Start Up Associate II / Submission Specialist / Study Start Up Lead for a hybrid role in Sofia, Bulgaria to lead the initiation of clinical trials, ensuring regulatory compliance and contributing to the advancement of innovative treatments. What You'll Do

• 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. What We're Looking For
• Bachelor's degree in life sciences or 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
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Willingness to travel approximately 5% Compensation & Benefits
• Competitive salary
• Various annual leave entitlements
• Health insurance offerings
• Competitive retirement planning offerings
• Global Employee Assistance Programme LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals for well-being support
• 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.