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    Tmf Specialist - Remote

    Lifelancer
    2+ years
    Not Disclosed
    Bangalore Bengaluru
    10 May 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: TMF Specialist - Remote

    Company: LifeLancer

    Experience: 2+ years

    Location: Bengaluru (Remote)

    About the Job:

    The TMF Specialist at LifeLancer is responsible for efficiently processing essential and non-essential clinical trial documents to support study startup, drug shipment, eTMF maintenance, and eTMF inspection readiness activities. This role involves interacting with clinical and regulatory teams to manage document receipt, analysis, classification, and disposition.

    Responsibilities:

    • Timely processing of essential and non-essential clinical trial documents.
    • Facilitate study startup, drug shipment, and eTMF maintenance.
    • Support eTMF inspection readiness activities.
    • Interact with clinical and regulatory teams regarding document handling.
    • Ensure proper receipt, analysis, classification, and disposition of documents.
    • Maintain good verbal and written communication skills in English and local languages.
    • Pay attention to detail and ability to manage multiple tasks simultaneously.
    • Strong problem-solving, time management, and organizational skills.
    • Proficiency in using MS Office software including Word, Excel, Access, SharePoint, and Outlook.

    Qualifications:

    • Bachelor's degree in Sciences is required.
    • Preferred: 2+ years of experience in the pharmaceutical or contract research organization (CRO) industry.
    • Knowledge of Essential Documents Clinical Trial Documentation is preferred.

    Application:

    Apply through the following link for a quicker response: LifeLancer Job Application

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