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    제약/바이오전문 1등 헤드헌팅사 나우팜컨설팅

    코스닥 상장사 임상 CS (Clinical Scientist)

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    등록자 : 강대필상무 22-05-06 12:10

    기본정보

    코스닥 상장사 임상 CS (Clinical Scientist)

    임상

    과장~팀장

    무관

    무관

    서류전형 -> 1차면접 -> 2차면접

    2022-05-06

    채용시

    상세정보

    본문

    [Key Responsibilities]
     Support Study Director of Clinical Development with medical monitoring reports, safety reviews, site interactions,
       and reviewing TFLs, Responsible for analytic support of clinical trial data (safety and efficacy), including
       gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to
      Chief Medical Officer. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety
     Responsible for scientific leadership, design, analysis and reporting for all phase-appropriate and registration[1]enabling DMPK studies
       (e.g., bioavailability, ADME, bioequivalence, DDI, food-effect, PKPD modeling)
     Work with cross-functional team with oversight by the Chief Medical Officer to conduct clinical studies, including
       clinical, pharmacokinetics and safety data review, site interface on clinical study content, preparation of meeting
       materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety
       and medical monitoring, preparation of status update reports, and study close-out activities
     Contribute to protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory
       documents under the direction of the Chief Medical Officer
     Interact with internal and external stakeholders (study sites, vendors, committee etc.) in support of clinical trial
       objectives; responds to or triages questions for appropriate escalations
     Represent MedPacto to outside personnel in the development of clinical protocols and study conduct
     Contribute to the organization, preparation, and execution of investigator and advisory board meetings in
       collaboration with the project team
     Prepare literature review as needed
     Support preparation of Scientific material for conference presentations or publications
     Collaborates with cross-functional teams for assigned studies

     [ Background Education & Qualification Requirements]
     Life Science degree (preferred PhD or Master in Biomedical sciences and related academic field) with 2~3+
       years of clinical or pre-clinical research experience in the pharmaceutical of healthcare setting
     Experience in analysis and interpretation of clinical data (pharmacokinetics, safety and efficacy); working
       knowledge of biostatics, GCP, and regulatory requirements for clinical studies
     Excellent oral and written communication skills and solid computer/analytical skills
     Ability to work collaboratively with agility, team-based matrix environment and to function independently as appropriate
     Project management skills
     Ability to handle multiple projects as a time and have a strong attention to detail while understanding the higher