Study Start-Up Specialist
hace 3 semanas
This challenging role involves leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.
Key Responsibilities:
- 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.
Requirements
An ideal candidate will have a Bachelor's degree in life sciences or a related field and a 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, is essential. Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously, are also required. Fluency in English is a must, and proficiency in Dutch is highly valued.
What ICON Offers
At ICON Plc, we offer a competitive salary, a range of additional benefits, and a dynamic work environment that rewards high performance and nurtures talent. Our benefits package includes various annual leave entitlements, a range of health insurance offerings, competitive retirement planning, and a global Employee Assistance Programme.
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