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Clinical Trial Assistant (m/w/d)
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 global leading 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 190,000 products sold globally. The company markets and sells its products in over 80 countries and has around 330 employees.
Position: Clinical Trial AssistantLocation: Onsite (Jena, Germany or İstanbul, Türkiye)
Work model: Full time
The Occlutech R&D team is responsible for the innovative development of new cardiac implant devices that enable physicians all over the world to save human lives every day. This motivated team of people works together and always focus on helping our customers to save and improve patientâs lives with innovative and highest quality products.
Your primary responsibilities as Senior R&D Engineer are innovation and new product development as well as common maintenance activities. This will include working together closely with Physicians, Marketing and Sales and all internal functions at the Company's international sites in Germany, Turkey and Sweden.
Your work will focus on- Close cooperation with our Clinical Research Manager, Associates and Project managers and actively support them with routine tasks e.g. Preparation and Maintain Sponsor Files Trial Master Files(TMFs) and Investigator Files including electronic TMFs (e TMFs)
- Preparation of study-specific documents
- Support Clinical Project Management in any study activities
- Tracking and recording of Study Documents
- Prepare and document Team meetings and meeting minutes
- Preparation of submission to Ethics Committee and tracking status together with CPMs
- Tracking budget of studies with CPMs
- Managing and updating e-Clinical Trial Management System
- Follow-up with sites in timely safety reporting for SAEs
- Has a degree in Health care, Health Science, Natural Science or comparable
- Has already a minimum of 2 years of professional experience in clinical research, experience in health or medical device industry
- Communicates well in German and English (Level B2.2)
- Is able to work independently, adapt to changing tasks in a fast and dynamic work environment and manage multiple tasks
- Is a team player who likes to work in a dynamic international environment
- Has good organizational, interpersonal and problem-solving skills and is able to collaborate with cross-functional teams
- Is proficient in Microsoft Office applications and relevants software programs (CTMS, e TMF, and e CRFs)
- A secure job in the medical device industry in 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 to bewerbung@occlutech.com. Only applications in English will be evaluated.
Occlutech Gmb HWinzerlaer Str. 2
07745 Jena
www.occlutech.com