Kategorie
sonstige Berufe
Frühster Einstellungstermin
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Einkommen
Keine Angabe / VB
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Beschreibung
Clinical Project ManagerOcclutech 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 85 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at www.occlutech.com.
Location: Jena The Clinical Project Manager plays an important role in the development and registration process for our products. He / she is well experienced in clinical trials and conducts clinical trials from preparation and approval to monitoring of ongoing studies. He / she is in close contact with the relevant authorities as well as with investigators and sites
- Conducting clinical trials, clinical studies and registries according to all applicable regulations and guidelines
- Planning, preparing and managing of all monitoring related activities and performance of monitoring of trials / registriy sites.
- Assisting in study audits
- Communication between investigators and site staff at Occlutech
- Providing regular updates to Clinical Research Manager
- Contributing to the Occlutech QM system
- Has an university degree (minimum Bachelor of Science)
- Has a minimum of 5 years’ experience in the filed of clilnical research of which 2 years must have been in a project lead role
- Has profound knowledge of relevant government regulations, standards and guidelines and experience on Medical Device Regulation (MDR)
- Has strong analytical and problemsolving skills and excellent interpersonal and communicational skills
- Is a team player who likes to work in a dynamic international environment
- Has experience in using clinical trial management systems
- Has proficiency with ICH, and GCP, ISO
- Is open to travel when needed
- Has excellent knowledge of English and excellent communication skills