Trial Documentation Specialist (m/f)

REFERENZNUMMER:

288338/11

IHRE AUFGABEN:

-Ensure Trial Master File (TMF)/electronic Trial Master File (eTMF) are audit-/inspection-ready
-Ensure accurate set-up, maintenance and archiving of the TMF/eTMF within timelines
-Track and review TMF/eTMF documents for completeness, accuracy and quality within timelines while maintaining consistency and attention to detail
-Ensure documents are coded, indexed, scanned and imported into the TMF/eTMF once the quality review is completed
-Create, track, and resolve document quality issues and/or missing documents in CTMS system
-Liaise with internal and regional teams to ensure document collection
-Escalate issues that may impact the TMF/eTMF
-Oversee the quality of the work done by any additional resources used for documentation-related tasks

IHRE QUALIFIKATIONEN:

-High school diploma, college education preferred
-Profound administrative and clerical experience, preferably in a pharmaceutical setting
-Prior experience in working with electronic filing systems
-Strong computer skills, including working with the Microsoft Office Suite
-Demonstrated oral and written communication skills
-Fluency in English; fluency in other languages is advantageous
-Willingness to travel (less than 5% per year)

WEITERE QUALIFIKATIONEN:

Clinical trial assistant