TMF Specialist Document Management Specialist mfd
TMF Specialist Document Management Specialist mfd
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 :
- You possess a completed science degree in life sciences healthcare or Medical Documentation (Med. Dokumentation) or an equivalent field.
- A minimum of several years of demonstrable experience in professional Trial Master File (TMF) management is essential comprehensive knowledge of the DIA reference model is required.
- Proficiency in TMF management is crucial as well as extensive experience in document uploading reviewing quality control (QC) and approval of studyrequired documents is mandatory.
- Strong attention to detail and ability to maintain the highest standards of document management are imperative and excellent organisational skills and the capacity to manage multiple priorities effectively are essential.
- Proficient communication skills in both written and verbal English are required.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
