Innovation needs coordination
New Valve Technology is a European company. It combines Swiss financial standing with German engineering expertise. Our innovative strength, our competence and the meticulous way we work ensure the highest possible quality in light of an ever-growing product portfolio. Our focus is on developing minimally invasive technologies for treating valvular heart disease, not on short-term profit maximization. That makes the company independent. We not only want to commit to sustainability, we need to and can afford to.
We are models of integrity and responsibility in our thinking and actions. We work closely with hospitals, physicians and public authorities. We maintain direct and personal contact with them and emphasize trust.
Trust is the defining factor in our long-term business relationships: trust in New Valve Technology, our employees, our products and services.
The cornerstone of this approach is open communication, transparent and clearly written product information, robust and carefully reviewed studies, and employees who are as qualified as they are experienced …… employees like you.
Clinical Project Manager m/w/d Knowledge/Skills and Abilities:
- Bachelor degree or equivalent education/degree in life science/healthcare required with > 6 years’ experience in clinical research activities in industry or CRO, and > 3 years’ experience in clinical study management activities
- Thorough knowledge of clinical study design and safety reporting in pre- and post-market studies
- Excellent knowledge of ISO 14155, GCP and MDR
- Knowledge of regulatory requirements and device regulations across different regions
- Proven project management experience and leadership in cross-functional, multicultural and international clinical study or registry teams
- Sound knowledge of MS office
- Excellent communication skills in English and German (oral and written), a further EU language is a plus
- Self-motivation and strong professional communication and interpersonal skills
- Excellent planning, time management and coordination skills
- Medical device experience in the cardiovascular field is a plus
- Set up and manage clinical studies or registries, including budget, timelines, communication, roles and responsibilities, training, risk management and manage involved CROs and other suppliers for outsourced activities, as applicable
- Develop and/or review relevant study documents like protocol, Investigator’s Brochure, CRF and study reports
- Manage clinical device supplies and logistics
- Oversee the site selection process and the clinical study agreements
- Continually monitor site performance and motivation. Ensure good communication with sites
- Ensure full compliance with safety reporting requirements according to applicable regulations
- Responsible for implementation of best practices and standards in the study/registry, and readiness for audits
- Conduct regular team meetings, with decisions and actions well documented
- Keep abreast of regulatory requirements for clinical studies and registries
- A family atmosphere in an innovative environment where your opinion counts.
- Attractive personal development opportunities
- Employee Bonus System
- BAV contribution 20%
Felix Müller, jobs[AT]nvt-med.com , T (0)-170
NVT GmbH, Lotzenäcker 17, 72379 Hechingen,
Reference No.: YF (please specify in the application)
Clinical Project Manager m/w/d Festanstellung Vollzeit NVT GmbH Hechingen bei Tübingen Chemie, Pharma & Medizin allg.,Weitere: Chemie, Pharma & Medizin Forschung, Wissenschaft,Biotechnologie,Projektmanagement Festanstellung Vollzeit Mit Berufserfahrung New Valve Technology entwickelt, produziert und vermarktet Medizinprodukte für die interventionelle Kardiologie und Herzchirurgie zur minimalinvasiven Behandlung von Herzklappenerkrankungen.