TMF Specialist

Job Overview
The role involves comprehensive TMF review including crosscheck and co-dependency checks to ensure inspection readiness of TMF.

Serve as the liaison between Records Management and user departments regarding Trial Master files. Apply  Records Management expertise to provide project related assistance across complex and multiple project(s), sites, and project 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.

The role involves contributing subject matter expertise to enhance and support the file review process and function.

• Essential Functions
  • Ensure project deadlines, commitments, and goals are met by monitoring team’s daily outputs.
  • Coordinate the retrieval of records requested by users and prepare closed studies for transfer to clients.
  • Monitor filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs).
  • Maintain records center security to protect record integrity by ensuring compliance to SOPs.
  • Interface with departments to support retrieval projects and ensure information needs are met.
  • Monitor and assist in the preparation of closed studies for transfer to clients per agreed due dates.
  • Train team members on records management tasks, policies, and procedures
  • Serve as primary contact for clients.
  • 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.
  • Assist management with the implementation of strategic goals, plans, cost proposals, and resource projections for records management projects.
  • Conduct and manage  processes and train staff on processes.
  • May function as team leader for records management projects.

• Qualifications
  • High School Diploma or equivalent  Req
  • 12 months experience working in a Records Management environment. Equivalent combination of education, training and experience.
  • Strong knowledge of applicable research and 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 management environments.
  • Ability to perceive and analyze 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.
  • Ability to establish and maintain effective working relationships with internal and external clients.
  • Ability to lead others.
  • Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
  • Regular sitting for extended periods of time.

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