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    Manager Clinical Trial

    Daiichi-Sankyo
    4+ years
    Not Disclosed
    Basking Ridge
    15 June 11, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Opportunity: Clinical Trial Information Disclosure Manager

    Employer: Daiichi Sankyo, Inc.
    Location: Basking Ridge, New Jersey (NJ), United States
    Job Type: Full Time
    Job Code: J3N6TY6BMST4DQ30T6N
    Category: Regulatory Affairs
    Post Date: 06/07/2024

    Description:

    Join Daiichi Sankyo, a global pharmaceutical leader dedicated to delivering innovative therapies and improving healthcare worldwide. As a Clinical Trial Information Disclosure Manager, you will play a pivotal role in ensuring compliance with global disclosure regulations and principles, contributing to our mission of addressing unmet medical needs.

    Summary:

    The Clinical Trial Information Disclosure Manager oversees company operational activities to adhere to US, EU, Japan, and other regional disclosure regulations, as well as international principles. As a member of the Global Clinical Trial Disclosure Platform and Operations Committee, you will lead initiatives to ensure compliance with current requirements and contribute to strategic planning for future changes.

    Responsibilities:

    • Coordinate company initiatives to comply with global trial disclosure regulations and principles.
    • Act as a subject matter expert on clinical trial registration, result posting, plain language summary, redaction/anonymization, and data sharing requirements.
    • Monitor and assess regulatory requirements, develop compliant processes, and provide guidance to project teams.
    • Build strong relationships with key stakeholders across functions and foster awareness of clinical trial information disclosure.
    • Provide oversight for trial disclosure processes and manage vendors and CROs.
    • Communicate internal compliance metrics and act as the lead Data Sharing Coordinator.
    • Lead or co-lead global process development and procedural document drafting.
    • Ensure timely responses to queries and review requests for clinical trial data.
    • Draft agendas, minutes, and lead actions for trial disclosure-related meetings.

    Qualifications:

    • Education:

      • Bachelor's Degree in pharmacy, biology, chemistry, medicine, or equivalent required.
      • Master's of Science Degree preferred.

    • Experience:

      • 4 or more years of experience with a Bachelor's Degree in the pharmaceutical industry, with clinical trial information disclosure experience highly desirable.
      • 1 or more years of experience with a Master's of Science degree.
      • Working knowledge of global laws, regulations, and guidelines related to clinical trial documents and data disclosure preferred.
      • General knowledge of global pharmaceutical legislation preferred.

    Travel: Ability to travel up to 10%, including international travel for workshops, interactions with external regulators, industry bodies, and stakeholders.

    Note: Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer.

    Please ensure you apply to the job posting no later than the day BEFORE the job posting end date.

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