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Clinical Expert Inspection Readiness (M/F/D)
Tasks:
Follow-up and resolution of internal audit findings
Ensuring compliance to quality standards (GCP)
Checking and managing the Trial Master File to be audit-ready
Contributing to trial management activities, such as data checks while working closely with CTA and CTM
Close cooperation with two CROs to close findings
Reporting and close cooperation with the inspection oversight team
Updating of SOPs (10%)
Qualification:
Solid knowledge of the principles in conducting clinical trials
Experience with (FDA) Inspection
Audit-readiness experience
High level of self-organization, structured, and independent working style
Proactive communication and team player
Experience with Veeva eTMF System
Excellent English
Basic data:
Start: ideally beginning of March, latest mid-March
Dauer: 6 months
FTE: 0.5 with ramp-up to 0.8/1.0 in a couple of months
Location: remote
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