Job Description
Study Start Up Associate II role requiring Fluent Dutch, leading clinical trial initiation, ensuring regulatory compliance, and advancing innovative treatments.
We're proud to foster an inclusive environment driving innovation and excellence at ICON plc, a world-leading healthcare intelligence and clinical research organization.
**Study Start Up Associate II**
We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. As a key member of our 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 ICON can offer you:**
Competitive salary and range of additional benefits, including:
• Various annual leave entitlements
• Health insurance offerings to suit you and your family's needs
• Retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme
• Flexible country-specific optional benefits
