Clinical Expert Inspection Readiness (m/f/d)

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