Responsibilities:
– Leading the operational planning, tracking, and closure of clinical studies for medical devices
– Leading collaboration with cross functional teams to secure support necessary for clinical studies
– Proactively engaging with clinical and business leadership to report on study status and present scenarios for maintaining on-time and on-budget study progress
– Preparing and reviewing essential study documents while ensuring that clinical studies are conducted in compliance with relevant regulatory requirements and internal procedures
– Ensuring on time submission to and communication with ethics committees and authorities
– Providing oversight for Trial Master File development, maintenance, and reconciliation through onsite and remote monitoring
Qualifications:
– Bachelor’s degree in a medically related discipline and further training in clinical study management
– 5+ years of experience with clinical studies including expert understanding of regulations for clinical study conduct (e.g. ISO 14155; EU Medical Device Regulation)
– Exceptional spoken and written communication ability in English and German to build rapport with collaborators from different cultural and educational backgrounds
– Willingness to travel (up to 10%) to clinical study centers, conferences, corporate events
– Solution-oriented mindset, open to continuous improvement
– IT skills: Microsoft Office, ideally familiar with project management and electronic data capturing systems
Benefits:
– Exciting and challenging work environment
– Collaborative culture with mutual trust in a highly motivated, international team
– Permanent contract and flexible working times
– Attractive pay according to achievement
– 30 days annual holiday
– Training and development opportunities with personalized development plans
– A workplace that values diversity and inclusion
– Opportunity to help improve the quality of life of millions of people