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Maidenhead

    Field Clinical Research Specialist - Maidenhead, Berkshire, United Kingdom - Consult

    Consult
    Consult Maidenhead, Berkshire, United Kingdom

    21 hours ago

    Default job background
    Description
    Maidenhead Very competitive salary
    Hybrid working 2x a week
    Initial 12 month contract which is likely to be extended

    This is an excellent opportunity for an experienced CTS Coordinator to join a global pharmaceutical company for an initial 12 months, with the potential for this to be extended.

    This role has come about due to expansion and an increase in the production of pharmaceuticals.

    This is a supportive role looking at completion of company databases and submissions tracking and would suit someone who is looking to get experience of the pharmaceutical industry, particularly regulatory affairs within clinical trials.

    Offer guidance on submission strategy, country-specific requirements, and operational assistance for Regulatory submission preparation and processing of amendments.


    • Demonstrate a thorough understanding of the Clinical Trial Regulation (CTR) process and its requirements.
    • Track key project milestones, compare actual progress with planned activities and timelines, and communicate any issues or changes to relevant stakeholders and management in accordance with company procedures.
    • Populate relevant databases and activity trackers within agreed timelines, ensuring compliance with reporting requirements, and provide operational support for Regulatory and/or non-Regulatory systems critical for Regulatory submission and maintenance activities.
    2 years of CTA experience, with a preference for involvement in global clinical trial submissions to regulatory agencies.
    ~ ability to work effectively across diverse cultures and within complex matrix environments.
    ~ in Information Technology, including MS Word, Excel, PowerPoint, Adobe Acrobat, and global databases.
    ~ high levels of initiative and independence, along with strong interpersonal skills and the ability to establish and maintain working relationships across remote geographical locations.
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