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principal / senior submissions coordinator.

job details

summary

    job details

    about the company.

    Our client, a world leader CRO, offers world class services in clinical trial logistics, development and manufacturing of the drug product. Looking to expand their Clinical Operations team in Hong Kong office to contribute to the future of drug discovery.

    about the job.

    • Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
    • Prepare, review, and submit to Regulatory Agencies;
    • Communicate with global study teams and personnel on study progress;
    • Ability to effectively identify risks to site activations and mitigate as necessary;
    • Provide expertise and guidance to global study teams in ethics and regulatory submissions;
    • Review and finalize essential documents required for site activation;
    • Act as a main contact for Ethical and Regulatory submission-related activities;
    • Direct contact with investigative sites during the study start up and activation process;
    • Ensure submissions comply with applicable regulations and guidance documents;
    • Advise sponsors on changing regulations and compliance requirements; and
    • Track submissions and ensure timely filing of documents.

    skills & experiences required.

    • Bachelor's degree in the science field or equivalent combination of education and experience;
    • At least four years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
    • Excellent organization and communication skills;
    • Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines;
    • Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and
    • Good command in English and Fluent in Cantonese.



    Interested individuals can click apply now and send through an updated resume in WORD format. For a more comprehensive list of current opportunities, please visit https://www.randstad.com/jobs/q-hong-kong/ or contact Boris Lee at + 852 2232 3497 or email boris.lee@randstad.com.hk

    #humanforward

    about the company.

    Our client, a world leader CRO, offers world class services in clinical trial logistics, development and manufacturing of the drug product. Looking to expand their Clinical Operations team in Hong Kong office to contribute to the future of drug discovery.

    about the job.

    • Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
    • Prepare, review, and submit to Regulatory Agencies;
    • Communicate with global study teams and personnel on study progress;
    • Ability to effectively identify risks to site activations and mitigate as necessary;
    • Provide expertise and guidance to global study teams in ethics and regulatory submissions;
    • Review and finalize essential documents required for site activation;
    • Act as a main contact for Ethical and Regulatory submission-related activities;
    • Direct contact with investigative sites during the study start up and activation process;
    • Ensure submissions comply with applicable regulations and guidance documents;
    • Advise sponsors on changing regulations and compliance requirements; and
    • Track submissions and ensure timely filing of documents.

    skills & experiences required.

    • Bachelor's degree in the science field or equivalent combination of education and experience;
    • At least four years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
    • Excellent organization and communication skills;
    • Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines;
    • Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and
    • Good command in English and Fluent in Cantonese.



    Interested individuals can click apply now and send through an updated resume in WORD format. For a more comprehensive list of current opportunities, please visit https://www.randstad.com/jobs/q-hong-kong/ or contact Boris Lee at + 852 2232 3497 or email boris.lee@randstad.com.hk

    #humanforward