Sr TMF Analyst

Requirements

• Bachelor's Degree Records management or related field Req
• At least 5 years' experience working in a Records Management technically-related area. 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.

Benefits

Additional Information

Job Overview 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 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. May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Essential Functions: Quality Control (QC): Meticulously reviews essential clinical documents to ensure they meet ALCOA++ principles, ICH-GCP guidelines, and Good Documentation Practices (GDP). Metadata & Indexing: Uploads, classifies, and verifies document metadata (e.g., document dates, types, version control) to ensure easy retrieval. Completeness Tracking: Reviews files against the Expected Document List (EDL) to identify missing pages or files, ensuring documents are never misfiled. Audit Readiness: Maintains the eTMF in a permanent state of inspection readiness, supporting study teams and regulatory authorities during clinical audits. Collaboration: Works closely with Clinical Research Associates (CRAs), TMF managers, and cross-functional study teams to resolve discrepancies. - Ensure that project timelines are met and facilitate the orderly transfer, imaging, scanning, retention, and disposition of various project-related and business records Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices 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 destination within agreed timelines Monitor filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs); Conduct and manage imaging/scanning processes and train staff on imaging/scanning processes 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 Train team members on records management tasks, policies, and procedures Serve as primary contact for internal and external 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 May function as team leader for records management projects

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Company Intel

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