Study Start Up Associate

• Support operational aspects of clinical trial submissions under the EU Clinical Trial Regulation in CTIS
• Support the Clinical Trial Submission Coordinator, Regulatory SM, and country teams with initial submissions, amendments, and notifications
• Generate progress tracking reports, analyze and follow up on progress
• Perform system data entry and maintain submission information
• Set up meetings, maintain minutes, and follow up on actions and decisions
• Manage, collate, quality-check, and transfer submission documents into CTIS
• Make submissions in CTIS and perform submission archiving
• Maintain current, complete, and accurate submission status data in CTMS
• Support submission coordination, timeline tracking, dashboards, metrics, quality oversight, and inspection readiness activities

• Bachelor's degree in life sciences or a related field
• Previous experience in start up (submission area on local level) min. 1 year
• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment
• Legal right to work in Poland

• 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