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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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.
- May lead teams functionally, where assigned, including awareness of scope of work, budget, and available resources.
- Ensure project timelines are met and facilitate the orderly transfer, imaging, scanning, retention, and disposition of project-related and business records.
- 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.
- 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.
Requirements
What you’ll need- 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) is highly preferred.
- 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.
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
records managementTrial Master File (TMF)imagingscanningproject managementcompliance monitoringdata analysisproblem solvingquality assuranceregulatory requirements
Soft Skills
attention to detailorganizational skillsplanning skillsdecision-making skillscommunication skillsinterpersonal skillsleadershiptime managementability to manage multiple tasksability to work under pressure
Certifications
Bachelor’s degree in Records Managementcertification in clinical researchcertification in records management
