Clinical Research Associate (m/w/d) für Jena gesucht
Arbeits- und Stellenangebot im Regiobizz Arbeitsmarkt
Job Kategorie: Medizintechnik Medizin/Pharma/Pflege
Stellenangebot Basisdaten
- Arbeitsort:
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DE 07745 Jena
- Umkreis:
-
keine Angabe.
- Art der Arbeitsstelle:
-
- Letze Aktualisierung:
-
02.10.20242024-10-02
Stellenausschreibung: Clinical Research Associate (m/w/d)
- Arbeitgeber bzw.
Arbeitsvermittler
-
Occlutech GmbH in Hamburg
- Branche
-
Medizintechnik
- Kategorie
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Medizin/Pharma/Pflege
- Stellenbeschreibung
- Einleitung We are offering a position in the medicaldevice 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 knowledgesharing 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. Position: Clinical Research Associate
Work model: Full time (40 hours/week) Work place: remote with
availibility to travel to Jena (monthly) 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. Aufgaben Your work will focus on
Plan, prepare and manage all monitoring related activities,
performance of monitoring of trial / registry sites If required,
assist in Study audits Main line of communication between
investigators / site staff and Occlutech Conduct clinical trials,
clinical studies and registries according to all applicable
regulations, to commonly accepted practices, and to Occlutech’s
internal guidelines, i.e. 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 on a regular basis, Oversee and lead
subcontractors such as, but not limited to, data management, local
monitors 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 Qualifikation We are looking for a candidate, who Has a
university degree (min. Bachelor) preferably Master’s degree in life
sciences or engineering or natural sciences Has at least 3 years of
professional experience in the field of Clinical Research 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 Benefits Our
benefits 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 Noch ein paar Worte zum Schluss
Ready to apply? We look forwardto receiving your application (cover
letter and CV). Only applications in English will be evaluated. 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 Telephone +49 3641 508 385 Occlutech GmbH Winzerlaer
Strasse 2- 07745 Jena
- Qualifikation
- Arbeitskräfte
- Verdienst:
- n.a.
- Bewerbung an
- Occlutech GmbH
Am Strandkai 1
De 20457 Hamburg
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