Join us in our exciting journey!!

We currently require a motivated, passionate and enthusiastic clinical trials professional to join our team

As an experienced Clinical Files Specialist, you could perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

IQVIA is expanding in Bulgaria, Don't miss this opportunity and join us working with different colleagues based across EMEA.

Essential Functions

• Assist the different member of the team on accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist in the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
• May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Qualifications

• Knowledge i.e., Good Clinical Practice y(GCP) and International Conference on Harmonization (ICH) guidelines and electronic tools (CTMS and E-TMF Systems).
• Excellent organizational and problem-solving skills
• Effective time management skills
• Strong written and verbal communication skills including good command of English and Bulgarian (we would value other European languages)
• Bachelor's degree in a health care or other scientific discipline or educational equivalent
• Hybrid role, required to go to the offices of Sofia ome times per month (depending on project status).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com