Study Initiation Specialist Lead
hace 3 semanas
We are currently seeking a Study Initiation Specialist Lead to join our dynamic team. As a Sr. Study Start Up Associate 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.
Your 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 Skills and Qualifications:
- 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.
Benefits and Compensation:
- A competitive salary of $75,000 - $95,000 per year, depending on location and experience.
- A range of benefits, including various annual leave entitlements, health insurance offerings, retirement planning options, and flexible country-specific optional benefits.
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