Study Start Up Associate

• Lead the initiation of clinical trials
• Contribute to site start-up and activation activities
• Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Manage accurate records of regulatory submissions, approvals, and correspondence
• Provide guidance and support to study teams on regulatory requirements and study start-up best practices
• 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 3 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
• Legal right to work in Romania

• Competitive base salary
• 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