Description
Serve as the liaison between Records Management and user departments regarding Trial Master Files. Apply clinical research records management expertise to provide project-related assistance across multiple projects, sites, and project teams. Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, Good Clinical Practice (GCP), and applicable regulatory requirements, while meeting quality and timeline metrics.
Essential Functions
- Ensure project timelines are met and facilitate the orderly transfer, imaging, scanning, retention, and disposition of project-related and business records.
- Ensure all work is conducted in accordance with SOPs, policies, practices, Good Clinical Practice (GCP), and applicable regulatory requirements, and meets quality and timeline metrics.
- Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destinations within agreed timelines.
- Monitor filing accuracy and compliance with IQVIA or customer file plans and Standard Operating Procedures (SOPs).
- Conduct and manage imaging and scanning processes, and train staff on applicable imaging and scanning procedures.
- Maintain records center security to protect record integrity by ensuring compliance with SOPs.
- Interface with internal departments to support retrieval projects and ensure information needs are met.
- Train team members on records management tasks, policies, and procedures.
- Serve as the primary point of contact for internal and external clients.
- Coordinate the transfer, recall, and disposition of records to commercial records storage centers.
- Oversee the 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.
- May function as team leader for records management projects.
Qualifications
- Bachelor’s degree in Records Management or a related field, or equivalent combination of education, training, and experience.
- Minimum of four (4) years of experience working in a technically related records management environment.
- Prior experience with Trial Master File (TMF) oversight, review and/or reconciliation across clinical studies
- Strong knowledge of applicable research and regulatory requirements, including International Council for Harmonization (ICH), Good Clinical Practice (GCP), and relevant local laws, regulations, and guidelines.
- Working knowledge of technology applications relevant to records management environments.
- Ability to identify and analyze problems, develop effective solutions, and make sound decisions.
- Demonstrated ability to manage multiple tasks and projects within defined timelines while balancing competing priorities.
- Strong attention to detail and ability to remain focused under pressure.
- Excellent organizational, planning, and decision-making skills.
- Strong written and verbal communication skills, including a solid command of the English language.
- Ability to establish and maintain effective working relationships with internal and external clients.
- Demonstrated ability to lead and guide others.