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    Local Study Associate Director/Clinical Trial Manager

    Hybrid
    Bangkok, Thailand
    Posted: August 14, 2024
    Position Details

    Major responsibilities:

    • Overall responsibility for project delivery in term of commitment, budget and time within the country
    • Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary. Proactively identify and resolution of study problems and issues.
    • Lead and optimize the performance of the local Study Team(s) at country level ensuring compliance with AZ SOPs, ICH-GCP and local regulations
    • Selection of potential Investigators considering capability, competence, etc., of the Hospitals/sites.
    • Ensure timely start-up of project from EC/IRB and Thai FDA submission to site initiation
    • Perform co-monitoring & QC visits with study monitor(s)
    • Organize regular Local Study Team meetings on an agenda driven basis
    • Ensure completeness of the Trial Master File
    • Ensure accurate payments related to the study are performed.
    • Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and AZ Procedural Documents.
    • Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File.
    • Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and QA.
    • Prepare and maintain study budget at country level
    • Provide regular information to Line Managers at country level on studies and planned study milestones/key issues.


    Minimum Requirements and Preferred Background:

    • Minimum University degree, preferred in Pharmacy or healthcare-related field.
    • Minimum 5 years’ experience in Clinical Operations
    • Excellent knowledge of spoken and written Thai and English.
    • Good ability to learn and to adapt to work with IT systems.
    • Good project management, decision-making, coaching, interpersonal, negotiation skills.
    • Excellent communication skills, verbal and written and presentation skills.



    Skills
    Toxicology
    Clinical Operations
    Negotiation
    Coaching

    Functions
    Other
    Other

    Job Overview

    Job Type:

    Hybrid


    Company

    AstraZeneca plc logo

    AstraZeneca plc

    38 active jobs

    Industry:

    Healthcare & Pharmaceutical

    Ready to Apply?

    Submit your application now and take the next step in your career journey.

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