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    Experienced Study Start up Submissions Coordinator - Melbourne, Australia - Medpace, Inc.

    Medpace, Inc.
    Medpace, Inc. Melbourne, Australia

    14 hours ago

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    Description

    Job Summary

    We are looking for a Study Start up Submissions Coordinator to join our Clinical Operations team in Melbourne. This role is crucial for our success, and we need someone who is ready to tackle tasks and projects head-on. If you want to take your career to the next level in a dynamic environment, this might be the perfect fit for you.

    At our company, we value expertise and encourage our teams to use their unique skills for problem-solving and research. Our employees exemplify our values by working hard, meeting high expectations, and embracing challenges. In return, they gain exposure to exciting projects, career growth opportunities, and international recognition.

    Responsibilities

    • Activate investigative sites for clinical trials in the country;
    • Submit to Regulatory Agencies such as TGA and Medsafe;
    • Communicate study progress with global teams;
    • Identify and manage risks in site activations;
    • Guide global teams on ethics and regulatory submissions;
    • Prepare essential documents for site activation;
    • Handle Ethical and Regulatory submission-related activities;
    • Directly engage with investigative sites during activation;
    • Ensure submissions adhere to regulations;
    • Advise sponsors on compliance requirements;
    • Track submissions and ensure timely document filing.

    Qualifications

    • Bachelor's degree in a science field or equivalent;
    • Minimum 4 years of relevant experience in CRO, Pharma, or investigative site;
    • Experience with TGA regulatory applications;
    • Strong organization and communication skills;
    • Proficiency in Microsoft Office;
    • Knowledge of ICH-GCP and local regulatory guidelines;
    • Hands-on experience with regulatory documentation;
    • Proactive and eager to learn.

    Medpace Overview

    Medpace is a leading clinical CRO providing services to biotech, pharma, and medical device industries. With a mission to accelerate global medical therapeutics development through scientific expertise, we work across major therapeutic areas. Headquartered in Cincinnati, Ohio, we have a global presence and a diverse team.

    Why Medpace?

    Join us to make a difference and contribute to impactful research that shapes the future of healthcare. Our work has touched the lives of many, and we continue to strive for excellence in all we do.

    Medpace Perks

    • Hybrid work options where possible
    • Competitive PTO
    • Employee appreciation events
    • Health and wellness initiatives
    • Flexible work schedule
    • Competitive compensation and benefits
    • Structured career growth opportunities

    Awards

    • Forbes recognition as one of America's Best Mid-size Companies
    • CRO Leadership Awards for expertise and reliability

    What to Expect Next

    If your qualifications match, our team will reach out with next steps.

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