Interim Clinical Affairs Manager (60% - 80%) (m/f)

REFERENZNUMMER:

373900/1

IHRE AUFGABEN:

-Support cross-functional assessments of all potential clinical studies (pre- and post-market) and the regulatory requirements for such studies
-Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies
-Oversee and provide guidance on the development of study documents and study management, e.g. CIP, ICF, CRF, data management plan and quality review and tracking.
-Ensure conformity to ISO 14155, national laws, and applicable regulatory standards, by working with the applicable functional areas as needed.
-Perform clinical project management duties, leading pre and post market clinical studies as required.

IHRE QUALIFIKATIONEN:

-Degree in Life Sciences or equivalent education
-Experience in Clinical Affairs or Clinical Project Management
-English is a must have. German is a plus
-Experience with Medical Devices Class II or III
-Organizational skills and team spirit

WEITERE QUALIFIKATIONEN:

Clinical project manager