Occlutech is a leading specialist provider of minimally invasive cardiac devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a leading global specialist provider in cardiac devices, addressing congenital heart defects, stroke prevention, and heart failure.
Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with more than 139,000 products sold. The company markets and sells its products in approximately 85 countries and has around 300 employees.
We are looking for a Validation Specialist in Jena, Germany.
The Clinical Research Associate ensures the overall quality of clinical trials by monitoring study data and managing site adherence to the protocol, all applicable regulations, and related study documents. The CRA is the primary contact with the study site and serves as the liaison between clinical investigators and the sponsor.
Planning, preparing, and managing all monitoring-related activities, the performance of monitoring of trial/registry sites
Conducting clinical trials, clinical studies, and registries according to all applicable regulations, commonly accepted practices, and to Occlutech's internal guidelines, ie
Prepare essential documents according to ISO 14155, MDR
Care for submission approvals by Competent Authorities and favorable opinions by responsible Ethics Committees
Plan and track the course of the studies and update tracking lists
Liaise with study investigators and site staff regularly
Oversee and lead subcontractors such as, but not limited to, data management, local monitors
Assisting in study audits
Communication between investigators/site staff and Occlutech
Providing regular updates to CRM on trial status, plans, and bottlenecks
Contributing to the Occlutech QM system
A Bachelor's and/or a Master's degree in science or health-related field
A minimum of 3 years of experience in the field of clinical research
Knowledge of relevant government regulations, standards, and guidelines
Knowledge of Medical Device Regulation (MDR)
Strong analytical and problem-solving skills & excellent interpersonal and communication skills & team player.
Proven track record of working in a dynamic, international environment
Proficient user of computer applications, and software for the execution of daily project operations
Experienced in using a Clinical trial management system (CTMS) or equivalent
Ability to travel when it is needed
Excellent written and spoken English and German knowledge.
Excellent written and verbal communication skills are required. Demonstrated proficiency with ICH, GCP, and ISO is required
Working Conditions:
The CRA position is a remote position requiring about 75% traveling.
Family corporate culture
A secure and multifaceted job in medical technology
Company pension plan
Fresh fruit and drinks
Flextime
Work-life balance
Regular company events
If you enjoy working in a diverse, multicultural team we are looking for you to join our diverse team dedicated to improving the lives of patients.
Are you interested?
Please send your complete application documents (Letter of motivation, resume, references - all in one PDF file) including your salary requirements and the earliest possible start date.
For more information about our company, please visit us: