Clinical Data Manager (m/f/d) remote, full-time

• Review and development of clinical study documents such as clinical investigation protocols, case report forms, data management plans, data protection impact assessment
• Design, development, testing and validation of study data bases
• Provide trainings for project teams
• Review of clinical data and clarification of data discrepancies
• Assist in quality checks and participate in study audits/ inspections
• Create and provide comprehensive data export files
• Review, conduct and approve clinical data management SOPs
• Collaborate with internal and external partners, e.g. project manager, statistician, eCRF provider, IT, physicians, documentation staff
• Willingness to travel (10-20%)

• University / College degree (life sciences, health sciences, information technology or related subjects preferred) or former experience in a CRO/ MedTech or Pharma
• 3-5 years of data management experience in a clinical research environment
• Knowledge of the clinical study process, data management and clinical operations, knowledge in statistics is an advantage
• Excellent data processing and ideally programming/build skills
• Experience with different clinical data bases, experience with CASTOR eCRF is an advantage
• Knowledge of ICH, GCP, ISO14155, FDA Guidelines, GDPR and data management regulations and standards (e.g. CDASH/ CDISC)
• Very good English skills (written and spoken)
• Well organized and with attention to detail while keeping a “getting the job done” and “problem solving” attitude
• Work independently (and remotely if applicable) and yet be a great team player, ability to work in a hybrid team
• Microsoft Office (Word, Excel, PowerPoint, Outlook, Visio etc.)

• an international & dynamic team
• flexible working environment
• a comprehensive on-boarding
• possibility to evolve within the team
• a fair and motivating remuneration system
• pension scheme
• company events/company celebrations
• flat rate for drinks
• JobRad