Study Start Up Associate
hace 8 horas
We are seeking a highly organized and detail-oriented Study Start Up Associate to join our dynamic team. As a Study Start Up Associate, you will play a crucial role in leading the preparation and submission of regulatory documents, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.
Key Responsibilities:- Prepare and submit regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
- Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
- Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
- Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
- Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency.
- 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.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Fluency in English and Dutch language.
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a global Employee Assistance Programme.
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