Clinical Research Associate Director
hace 4 días
**Company Overview**
ICON Plc is a world-leading healthcare intelligence and clinical research organization. We pride ourselves on fostering an inclusive environment that drives innovation and excellence, and we welcome you to be part of our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate Director - Regulatory Affairs to join our diverse and dynamic team. As a key member of our regulatory affairs team, 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.
**Job Description**
As a Clinical Research Associate Director - Regulatory Affairs at ICON, your responsibilities will include:
- 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.
**Required Skills and Qualifications**
To be successful in this role, you will need:
- A Bachelor's degree in life sciences or a related field.
- A minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
- A 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.
**Salary and Benefits**
The estimated annual salary for this position is $85,000-$110,000, depending on location and experience. In addition to your competitive salary, ICON offers a range of benefits, including:
- Varying annual leave entitlements.
- A range of health insurance offerings to suit your needs.
- Competitive retirement planning offerings to maximize savings and plan for the future.
- A Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals who can support you and your family's well-being.
- Life assurance.
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
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