Project management specialist Jobs in Overath

In this role you will be responsible for collecting reviewing maintaining and archiving essential regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP) E6 ICH Guidelines and other regulatory guidance documents and Clinical Trials Regulation and our Standard Operating Procedures (SOPs).

• You are responsible for the TMF health including oversight and management of document submissions indexing and filing (both paper & electronic) QC / QR
• Management of periodic and / or sponsor QC reviews of the TMF to ensure completeness timeliness and quality of the TMF and works directly with the document owners to identify issues performs completeness checks and uploads documents to the eTMF and / or paper TMF as applicable
• Furthermore you develop metrics and reports and you have the oversight of the CRO studyspecific trial master files
• Training and mentoring activities for new and current staff to foster TMF awareness.

Qualifications :

Remote Work : Employment Type :

Fulltime

Key Skills

DRG,Acute Care,Adobe Acrobat,ICD-10,Records Management,Technical Writing,Clinical Documentation Improvement,Documentation Review,Sharepoint,cGMP,Document Management Systems,Document Management

Vacancy : 1