Introduction
Your Strenght
- Bachelor's degree in biological sciences, engineering
- Experience in Medical Devices (Plus)
- At least 5 years of experience in planning and executing clinical research studies or 3+ years with an advanced degree.
- Proven track record of managing multicenter investigational (e.g. IDE) studies preferably medical device studies.
- Strong project management and analytical skills with the ability to think critically and communicate effectively.
- In-depth knowledge of medical terminology and clinical documentation.
- Proficient in MS Office (Excel, Word, PowerPoint), project management tools, and web-based applications.
- Ability to travel domestically and internationally up to 30% of the time.
- Fluency in English.
Your Contribution
- Lead the development and management of clinical research projects from study design to close-out.
- Create and oversee clinical study documentation (e.g. protocols, CRFs, informed consents, investigator manuals).
- Act as primary contact for internal and external stakeholders including CROs, sites, monitors, and data managers.
- Coordinate and lead study team meetings, ensuring timeline adherence and risk mitigation.
- Submit studies to ethics committees/IRBs and manage responses to regulatory bodies.
- Ensure negotiation and finalization of clinical Study Agreements as per study budget and applicable regulation.
- Define and ensure fulfillment of adequate safety reporting as per local requirements.
- Collaborate with cross-functional teams including Quality, RA/QA, and Finance.
- Manage vendor selection and contract processes, including budget tracking and oversight.
- Support and ensure audit readiness, compliance, and proper documentation across all project stages.
- Contribute to clinical study reports and data verification processes in collaboration with statisticians.
- Contribute to internal and external communications (e.g. oral presentations, written publications).
Our Strenght
- A dynamic, international work environment with opportunities for innovation and leadership.
- Diverse and challenging projects with significant global impact.
- Opportunities for career growth and specialized training programs.
- Flexible working conditions, including hybrid options.
Contact
We look forward to receiving your application documents in English.
Brian Russo
T: +41 435 08 39 01
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.
Lotzenäcker 23, 72379 Hechingen
www.artivion.com
