Clinical Trial Assistant
Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company manufactures, develops, sells and markets Class III medical devices for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with atrial fibrillation or heart failure, in over 90 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at .
Position: Clinical Trial Assistant (CTA) (m/f/d) Location: Jena, Germany
The CTA will assist in the conduct of clinical trial activities such as to support in submission process, to ensure appropriate documentation and to prepare relevant trial specific documents and communication with trial sites.
A young and motivated team will welcome you to meet together the challenges of clinical research. After an introduction period, you will have freedom for self-organization to fulfill your tasks. We also offer opportunities for further professional development.
Your work will focus on
- Support in conduct of clinical studies and registries according to all applicable regulations, to commonly accepted practices, and to Occlutech’s internal guidelines.
- Preparation and Maintain Sponsor File (Trail Master Files) & Investigator Files
- Preparation of study-specific documents
- Support Clinical Project Management in any study activities
- Track record of Study Documents
- Prepare and documents Meetings
- Managing and updating e-Clinical Trial Management System
- Preparation submission together with CPMs
- Tracking budget of studies with CPMs
- If required, assist in study audits
- Contribute to the overall tasks of the Clinical Research department
- Perform other related duties and responsibilities, on occasion, as assigned
We are looking for a candidate, who has
- A Bachelor’s and/or a Master’ degree on science or health related field
- Professional Experience in medical device industry and/or clinical research (minimum of 2 years’)
- Knowledge of regulatory clinical research framework, standards and guidelines
- Excellent English skills, verbally and in writing (level B2.2)
- Professional Experience in medical device industry and/or clinical research
- Strong analytical and problem solving skills
- Hands-on working style
- Proven track record of working in a dynamic, international environment
- Excellent skills in relevant software programs (i.e. MS office, CTMS).
If you are
- a team player who likes challenges
- a confident user of standard office software
- excellent in communication, organization and time management
- open to international travel
Then we can offer you an interesting job in a team of people who like to work together and always focus on helping our customers to save and improve patient’s lives with innovative and highest quality products.
Are you interested?
We look forward to receiving your application (cover letter, CV, references – all documents in one pdf file), your salary expectation and the earliest possible date for start of work to .
Occlutech GmbH Winzerlaer Str. 2 D-07745 Jena
Occlutech GmbH Jena Winzerlaer Straße 2, 07745 Jena, Germany Tel ,
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