Clinical Trials Specialist Lead
hace 1 mes
Senior Study Start Up Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence, welcoming professionals to contribute to our mission shaping the future of clinical development. We seek a Senior Study Start Up Associate to join our diverse team. As a Sr. Study Start Up Associate at ICON, you will lead clinical trial initiation, ensure compliance with regulatory requirements, and advance innovative treatments.
About this roleEstimated salary: $85,000 - $110,000 per annum, depending on location and experience.
We are currently seeking a highly skilled professional to play a pivotal role in leading the initiation of clinical trials. Key responsibilities include:
- Leading the preparation and submission of regulatory documents, including clinical trial applications 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.
This role requires strong organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously. You should have a bachelor's degree in life sciences or a related field and minimum 2 years of experience in clinical research or regulatory affairs.
Your profile- Bachelor's degree in life sciences or a related field.
- Minimum 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.
We recognize that our success depends on the quality of our people. We aim to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, we offer a range of benefits designed to support your well-being and work-life balance, including various annual leave entitlements, health insurance offerings, retirement planning, and flexible country-specific optional benefits.
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