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    CDC Project Manager - Seoul, 대한민국. - Novo Nordisk

    Novo Nordisk
    Novo Nordisk Seoul, 대한민국.

    위치: Talent KR S2 - 6시간 전

    Novo Nordisk background
    풀타임
    설명
    The position
    As a CDC Project Manager, you are in charge for managing multiple clinical trials in Korea CDC, ensuring that deliverables are met according to project timelines, within budget, and in compliance with the protocol, regulatory requirements, International Conference on Harmonization – Good Clinical Practice (ICH-GCP), and Novo Nordisk Standard Operating Procedures (SOPs)

    Other tasks include:

    Manage trial activities from site selection to post-trial tasks, including organizing, communicating, conducting feasibility assessments, planning resources, assessing risks, and developing strategies for trial implementation.

    Serve as a key point of contact for Clinical Research Associate (CRA)s, Headquarter Trial Manager (TM)s, and Therapeutic Area Managers, ensuring timely communication of trial issues and compliance with Novo Nordisk policies.

    Additionally, be liaible for project timelines, deliverables, and country budget according to ClinCost procedures.

    Provide consolidated country input for document review, manage relationships with local Conversion Rate Optimization (CRO)s and vendors, and ensure regulatory approvals and Clinical Trial Management System (CTMS) updates.

    Monitor recruitment and retention of trial subjects, provide status updates to headquarters TMs, ensure data cleaning milestones, and oversee document filing and compliance with guidelines.

    In charge for escalating issues to local line manager, HQ TM and seeing to consistency between the trial sites and CRAs.

    Proactively drives clinical trial activities forward and delivers results that have a direct impact on the successful completion of the clinical program.

    In charge for the country budget of the assigned clinical trial(s). Qualifications Minimum bachelor's degree in pharmacy, life science or nursing is required. Previous experience in trial management and monitoring in clinical trials in accordance with ICH GCP.

    Trial and resource management skills, along with an understanding of clinical trial regulations, as well as excellent knowledge of clinical trial methodology, and up-to-date awareness of the clinical trials environment - including ICH GCP, regulatory issues, and SOPs.

    Completed GCP training and obtained a certificate, with knowledge of the drug development process.

    Computer literacy and IT skills include proficiency in SAP, CTMS, EDC, and eTMF, as well as strong communication skills in English.

    Working at Novo Nordisk At Novo Nordisk, we don't wait for change. We drive it.

    We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.

    We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them.

    From research and development, through to manufacturing, marketing and sales – we're all working to move the needle on patient care.

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