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Job Opening - eTMF Document Specialist - Gurgaon

1 - 3 yrs
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Not Disclosed by Recruiter Openings: 1 Posted 30 days ago Job Applicants: 843 Job Views: 3000+

Job Description

 
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    JOB SUMMARY

    Performs support tasks related to the set-up, maintenance and close out of the Trial Master File.

    JOB RESPONSIBILITIES

    Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans.
    Support the set-up, maintenance, and closure of TMF repositories.
    Support documentation collection activities, including:
    Document scanning and indexing for trial using an electronic TMF
    Document filing for trials using a paper TMF
    Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified
    Maintain compliance with departmental quality, performance and utilization targets
    Complete administrative tasks (e.g., status reports) as requested
    Maintain compliance with company requirements (e.g., time tracking, training)
    Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments.
    Participates in study specific training as required.
    For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room
    Ensures the security and compliance of all documents related to active and archived projects
    Performs other work-related duties as assigned. Occasional travel may be required (up to 10%).


    QUALIFICATION REQUIREMENTS

    Minimum Science graduate with some college courses in the scientific/regulatory field preferred.
    Some experience in a clinical trials environment preferred.
    Some knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology preferred.
    Familiarity with electronic TMF system preferred. Strong verbal, written and organizational skills with a team-oriented approach.
    Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.
    Proficiency in Microsoft Office Suite and Adobe Acrobat.
    Good communication skill.

Salary: Not Disclosed by Recruiter

Industry: Pharma, Biotech, Clinical Research

Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type: Full Time, Permanent

Keyskills

Company Profile:

inVentiv International Pharma Services Pvt. Ltd.

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You will work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
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