Study Start Up Associate II

• Lead the initiation of clinical trials and ensure compliance with regulatory requirements
• Contribute to site start-up and activation activities, taking responsibility for deliverables
• Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions
• Communicate with regulatory agencies
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Manage and maintain 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
• Collaborate with cross-functional teams

• 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
• Fluency in English and your local language plus German, French, Romanian, or Dutch
• 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%)
• Legal right to work in the country where the role is based

• 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