Übersicht

Clinical Project Manager

Occlutech 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 90 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at .

Location: Jena

The Clinical Project Managerplays 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
Your work will focus on

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 Bachelorof Science)
Has a minimum of 5 years’ experience in the filed of clilnical research of which 2years 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