Trial Master File Specialist (m/f)

-Support and advise the global clinical project management team members on the preparation of their clinical (e)Trial Master File for archiving
-Liaise with internal and regional teams to ensure completeness and quality of documents
-Ensure all (e)filing environments are ready on reception of the first original trial documents
-Support the creation of the (e)Trial Master File Table of Contents for new trials
-Ensure documents are scanned, imported, coded, and indexed into the (e)Trial Master File and reviewed for quality on an on-going basis
-Plan and perform periodical quality checks of (e)Trial Master Files to identify any filing issues
-Experienced by the Clinical Trial Teams to ensure the (e)Trial Master Files meet internal and external quality standards
-Support the trial management teams in the preparation, conduct, and follow up of internal and/or external audits/inspections
-Communicate all systematic filing issues to manager for further training evaluation
-Maintain an inventory of the clinical (e)Trial Master Files stored in the global clinical project management archiving room and a list tracking the status of each clinical trial
-Maintain a list of the clinical (e)Trial Master Files transferred to long term archive, including the actual transfer date and the responsible person for the transfer
-Other duties, activities, and projects as assigned
-Solid experience in prior administrative and clerical experience, preferably in a pharmaceutical setting
-Prior experience working with electronic filing systems
-Strong computer skills, including working with the Microsoft suite of programs
-Demonstrated oral and written communication skills
-Behavioural skills
-Results-driven
-Strong interpersonal skills; ability to work as an effective team member
-Highly detail-oriented with the ability to handle and prioritize multiple tasks
-Quality conscious

Weitere Qualifikationen: Clinical trial assistant