Trial Documentation Specialist

- 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 ongoing 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
- Behavioral 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 associate