Clinical Research Associate (m/w/d)

Clinical Research

We are offering a position in the medical device sector with ambitious and passionate people

building meaningful products for patients all over the world. Our work environment is agile and

allowing for collaboration with smart people and knowledge sharing in cross functional teams.

As a fast-growing organization, we provide ample room for development and our remote work policy

allows for more flexibility for our employees.

About the position

The Clinical Research Associate 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 Our benefits

• Plan, prepare and manage all monitoring related • A secure job in the medical device

activities, performance of monitoring of trial / industry in a family-friendly

• Conduct clinical trials, clinical studies and

training plan in the first 6 months

registries according to all applicable regulations,
to commonly accepted practices, and to • Company wide Mentoring program

Occlutech’s internal guidelines, i.e. • Good work-life balance through 30

days of vacation, flexible working

o Prepare Essential documents according to hours and hybrid, family-friendly

ISO 14155, MDR working time models
o Care for submission-approvals by • Employer-financed retirement

Competent Authorities and favorable insurance
opinions by responsible Ethics Committees • Team building, employee and

o Plan and track the course of the studies
company events

o Liaise with study investigators and site staff
on a regular basis Beutenberg Campus with an

o Oversee and lead subcontractors such as, attached canteen

but not limited to, data management, local • Healthy work culture with a fruit

monitors basket, tea, water and coffee as well

as regular team sporting events

• Provide regular updates to CRM on trial status,

plans and bottlenecks

• Contribute to Occlutech QM system (e.g. preparing

SOPs)

• Perform other related duties and responsibilities, on

occasion, as assigned

We are looking for a candidate, who Ready to apply?

• Has a university degree (min. Bachelor) We look forward to receiving your

preferably Master’s degree in life science or application (cover letter and CV to

engineering or natural sciences bewerbung@occlutech.com .

• Has at least 3 years of professional experience Only applications in English will be

in the field of Clinical Research evaluated.

• Has knowledge of Medical Device Regulation

(MDR)

• Demonstrates proficiency with ICH, and GCP,ISO

• Used to work in a dynamic, international

environment

• Has experience on using on Clinical trial

management system (CTMS) or equivalent

• Communicates well in German and English

• Is able to work independently, adapt to

changing tasks in a fast and dynamic work

environment and manage multiple tasks

• Has good organizational, interpersonal and

problem-solving skills and is able to

collaborate with cross-functional teams

• Is proficient in Microsoft Office applications

• Is able to travel when it is needed
  

About Occlutech

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. The company markets
and sells its products in over 80 countries and has around 330 employees.

Contact

Kristin Spanka |People & Culture Business Partner

Occlutech GmbH Winzerlaer Strasse 2- 07745 Jena

www.occlutech.com