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Sr TMF Analyst

IQVIA -
Bengaluru, Karnataka

Apply Now

Job details

Full-time
3 days ago

Qualifications

Clinical research
English
Research
Records management
Bachelor's degree
Communication skills

Full job description

Bengaluru, India | Full time | Hybrid | R1548066

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

Qualifications

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.

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

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.

Apply Now

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