TMF Document Specialist Hybrid (Bulgaria)

Sofia - Bulgaria

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Overview

Provide Trial Master File (TMF) - Quality checks related assistance to study teams.

Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs) policies practices good clinical practices applicable regulatory requirements and meets quality and timeline metrics.

Ensure that project timelines are met and facilitate the orderly imaging transfer retention and disposition of various project-related and business records. Administer records management systems.

Essential Functions

Perform assigned complex administrative tasks to support team members with project execution

Assist in updating and maintaining complex data in systems within project timelines and per project plans

Coordinate the retrieval of records requested by users and prepare closed studies to final destination within agreed timelines

Conduct and manage scanning processes and train staff on scanning processes

Interface with departments to support retrieval projects and ensure information needs are met

Serve as primary contact for internal/external clients

Monitor and review filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs) where applicable.

Maintain records center security to protect record integrity by ensuring compliance to SOPs

May coordinate transfer recall and disposition of records to commercial records storage centers

Oversee disposal of obsolete records and ensure efficient maintenance of records storage space supplies and equipment

Train team members on records management tasks policies and procedures

Establish and maintain effective internal and external client communications

Design and administer records management systems and processes

Ensure project deadlines commitments and goals are met by monitoring projects daily outputs

May function as team leader for records management projects

Qualifications

Bachelors degree or equivalent

3-4 years experience working in a Records Management technically-related area. Equivalent combination of education training and experience.

Good knowledge of applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) Good Clinical Practice (GCP) and relevant local laws regulations and guidelines;

Knowledge of technology applications relevant to records center environments.

Ability to perceive and analyse problems develop solutions and make sound decisions.
Ability to handle multiple tasks and projects within defined timelines and balance competing priorities.
Ability to remain focused with regards to details under pressure.
Strong organizational planning and decision making skills.
Excellent oral and written communication skills including good command of English language.

Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.

Position requires to stand walk sit use hands to manipulate handle or feel and reach with hands and arms.

Position requires to stoop kneel and may need to utilize a ladder for paper files on high-density file systems.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.

Required Experience:

Job OverviewProvide Trial Master File (TMF) - Quality checks related assistance to study teams.Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs) policies practices good clinical practices applicable regulatory requirements and meets quality and timeline metrics.Ens...