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Study Start Up Associate
hace 2 meses
Job Summary
At ICON Plc, we are seeking a highly skilled and experienced Study Start Up Associate II to join our dynamic team. As a key member of our clinical trials 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.
Key Responsibilities
- Lead the preparation and submission of 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.
Requirements
- 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.
What We Offer
- Competitive salary and benefits package.
- Opportunities for career growth and professional development.
- Collaborative and dynamic work environment.
- Recognition and rewards for high performance.