Study Start Up Associate
Location
Denmark
Posted
4 days ago
Salary
0
Seniority
Mid Level
Job Description
Study Start Up Associate
ICON plc
• Lead the initiation of clinical trials, ensuring compliance with regulatory requirements • Contribute to site start-up and activation activities, taking responsibility for deliverables and collaborating with others • Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions • Coordinate and liaise with internal and external stakeholders to obtain necessary approvals • Manage and maintain comprehensive and accurate records of regulatory submissions and correspondence • Provide guidance and support to study teams on regulatory requirements • Participate in process improvement initiatives to streamline study start-up processes
Job 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
- Willingness to travel as required (approximately 5%)
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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