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    Tmf Specilaist

    Icon
    2+ years
    Not Disclosed
    Chennai
    10 Oct. 17, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    About the Role

    As a TMF Specialist, you will be joining the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence.

    Key Responsibilities:

    • Ensure the consistent receipt, analysis, classification, registration, filing, and retrieval of electronic clinical trial essential and non-essential documents, along with other clinical trial-related documents.
    • Index documents in eTMF Veeva Vault with the required metadata.
    • Perform peer reviews to ensure that documents are in their final state.
    • Send rejection notifications using Microsoft Forms and communicate updates to the sender via email.
    • Run inactivation and reclassification reports and complete necessary tasks as needed.
    • Coordinate communications regarding the progress and completion of study documentation, package creation, and data entry activities across various functional areas.
    • Run and analyze reports.
    • Maintain weekly document processing metrics, including errors, returns, and delays, using Excel spreadsheets.
    • Oversee the processing of study document requests from cross-functional team members, ensuring all urgent requests and inquiries are addressed promptly.
    • Provide process training and mentoring to new RMSs.
    • Offer QC and audit support.
    • Coordinate, lead, and execute tasks related to weekly submission error reconciliation processes and report on completion and error metrics.
    • Coordinate, lead, and execute the QC process as per sponsor QCP, reporting on quality metrics for the team and individuals while communicating error trends and QC metrics.
    • Monitor, track, and report on rework and reclassification requests.

    Qualifications:

    • 2 to 4 years of experience in a pharmaceutical or contract research organization.
    • Ability to interact effectively with Clinical and Regulatory teams regarding the receipt, analysis, classification, and disposition of documents.
    • Demonstrated knowledge of essential clinical trial documentation.
    • Strong verbal and written communication skills in English and local language.
    • Exceptional attention to detail and the ability to multitask.
    • Proven problem-solving, time management, and organizational skills.

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