Study Start-Up Specialist
hace 2 días
**About ICON plc**
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Study Start-Up Specialist to join our diverse and dynamic team. As a Study Start-Up Specialist at ICON, you will play a pivotal role in 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.
Your Profile:
- 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.
- Fluency in English and Spanish.
About the Role:
The estimated salary for this position is around **£55,000 - £65,000 per annum**, depending on location and experience. Our benefits package includes various annual leave entitlements, health insurance, retirement planning options, and access to our Employee Assistance Programme, LifeWorks.
Why Choose ICON?
Diversity, inclusion & belonging are fundamental to our culture and values. At ICON, we strive to create an environment where everyone feels valued, respected, and empowered to contribute their best work. We believe that our differences are what make us stronger and more effective as a team.
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