Clinical Research Associate
vor 2 Wochen
We are seeking a highly motivated and experienced Clinical Research Associate to join our team at Occlutech GmbH. As a Clinical Research Associate, you will play a key role in the conduct of clinical trial activities, ensuring compliance with regulatory requirements and company policies.
Key Responsibilities- Plan, prepare, and manage all monitoring-related activities, including performance of monitoring of trial/registry sites
- Assist in study audits as required
- Establish and maintain communication with investigators/site staff and Occlutech
- Conduct clinical trials, studies, and registries in accordance with applicable regulations, commonly accepted practices, and Occlutech's internal guidelines
- Prepare essential documents according to ISO 14155, MDR, and other relevant regulations
- Liaise with study investigators and site staff on a regular basis
- Oversee and lead subcontractors, such as data management and local monitors
- Provide regular updates to CRM on trial status, plans, and bottlenecks
- Contribute to Occlutech's QM system, including preparing SOPs
- University degree (min. Bachelor) in life sciences or engineering or natural sciences
- At least 3 years of professional experience in clinical research
- Knowledge of Medical Device Regulation (MDR) and proficiency with ICH, GCP, and ISO
- Experience working in a dynamic, international environment
- Proficiency in using clinical trial management systems (CTMS) or equivalent
- Excellent communication skills in German and English
- Ability to work independently, adapt to changing tasks, and manage multiple tasks
- Good organizational, interpersonal, and problem-solving skills, with the ability to collaborate with cross-functional teams
- Proficiency in Microsoft Office applications
- A secure job in the medical device industry with a family-friendly working environment
- An interesting work scope in a growing international company
- Comprehensive onboarding and training plan in the first 6 months
- Company-wide mentoring program
- Good work-life balance through 30 days of vacation, flexible working hours, and hybrid, family-friendly working time models
- Employer-financed retirement insurance
- Team building, employee, and company events
- Easy access to the office on the Beutenberg Campus with an attached canteen
- Healthy work culture with a fruit basket, tea, water, and coffee, as well as regular team sporting events
We look forward to receiving your application (cover letter and CV) in English.
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