Clinical Trial Operations Specialist
hace 3 semanas
Job Description: We are seeking a highly skilled Clinical Trial Operations Specialist to join our team at ICON Plc, a world-leading healthcare intelligence and clinical research organization.
About Us:
We foster an inclusive environment driving innovation and excellence, and we welcome you to be a part of it. Our mission is to shape the future of clinical development, and we're proud of our diverse workforce and the work we've done to become a more inclusive organization.
The Role:
As a Clinical Trial Operations Specialist, 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 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:
To be successful in this role, you should have:
- 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 and Spanish.
What We Offer:
We offer a competitive salary of $85,000 - $110,000 per annum, depending on your experience and qualifications. In addition to your salary, you can expect:
- Varying annual leave entitlements.
- A range of health insurance offerings to suit your needs.
- Competitive retirement planning options.
- Global Employee Assistance Programme, TELUS Health, offering access to a global network of professionals who can support your well-being.
- Lifelong learning opportunities through our training and development programs.
Why Choose ICON?
We are committed to diversity, inclusion, and belonging. Our rich diversity makes us more innovative, allowing us to better serve our people, patients, customers, and communities. We are dedicated to providing an inclusive and accessible environment for all candidates.
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