IQVIA

Clinical Files Specialist, Hybrid (Bulgaria)

In short

This role handles daily administrative work to ensure complete and accurate Trial Master File (TMF) delivery, including document filing, archiving, site visit preparation, and acting as the clinical team's point of contact for TMF matters. The employer is IQVIA, a global clinical research and healthcare intelligence provider, hiring for its Sofia, Bulgaria team on a hybrid basis. Both entry-level candidates and experienced professionals are considered; good Excel skills and fluent English are required.

Job Overview
Perform daily administrative activities to ensure a complete and accurate Trial Master File (TMF) delivery.
Essential Functions
•Assist local project team members (i.e., CRA, CTA) with accurately updating and maintaining clinical documents and systems (Trial Master File) within project and company timelines.
•Assist the clinical team with the handling, filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
•Assist the clinical team with site visit preparation by identifying and sharing missing documents for TMF.
•Act as a central contact for the clinical team for TMF and associated documentation (including TMF set-up, periodic review, Action Item resolution).
Candidate Profile
•Education: Bachelor's degree (life sciences preferred); candidates pursuing a Bachelor's degree are also welcome to apply, if available for full-time employment.
•Experience: both candidates with limited/no experience and professionals can be considered. Admin experience, etc. is a plus.
•Good computer skills: processing large amounts of data in Excel (ideally, including basic formulas), experience of working with databases or trackers/tables. Knowledge of TMF a big plus, but not required.
•Detail-oriented: attention to detail, ability to focus on routine and prolonged tasks.
•Fluent in English.
•Work model: hybrid preferred. 1 month in the office preferred for onboarding.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

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