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    Manager, Clinical Data Management

    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 Title: Data Management Project Manager

    Company: Daiichi Sankyo, Inc.

    Category: Biostatistics

    Job Type: Full Time

    Location:

    • Country: United States
    • State: New Jersey (NJ)
    • City: Basking Ridge

    Post Date: 06/05/2024

    Company Description

    Join a Legacy of Innovation 110 Years and Counting!

    Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs globally by leveraging world-class science and technology. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees worldwide draw upon a rich legacy of innovation. The Group's 2025 Vision aims to become a "Global Pharma Innovator with Competitive Advantage in Oncology," focusing on novel therapies in oncology and research areas centered on rare diseases and immune disorders.

    Job Description

    Summary: The Data Management Project Manager manages the end-to-end delivery of data management services for assigned projects/studies. This role involves collaborating with CROs and other vendors to ensure high-quality deliverables on time and within budget to support drug development processes and global submissions. The position also involves optimizing Data Management technology, processes, and standards in partnership with internal and external stakeholders.

    Responsibilities:

    Leadership, Direction, and Strategy:

    • Establish Data Management strategy at the project and/or study level for a smaller number of projects/studies.
    • Proactively identify and manage risks at the project and/or study level for a smaller number of projects/studies.

    Project Management:

    • Plan and direct the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, conduct, closeout, and reporting).
    • Provide oversight for Data Management CRO and other third-party vendors to ensure compliance with protocols, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
    • Ensure Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements.

    Functional Expertise:

    • Review/approve clinical study-related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports).
    • Lead and drive the data review process in collaboration with the study team to ensure data quality.
    • Participate in audits and inspections.

    Operational Efficiency / Continuous Improvement:

    • Provide comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes.
    • Participate in process improvement initiatives.

    Qualifications

    Education:

    • Required: Bachelor's Degree in life sciences or related field (or equivalent experience).
    • Preferred: Master's Degree in life sciences or related field (or equivalent experience).

    Experience:

    • 4 or more years of data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO).

    Skills:

    • Working knowledge of Electronic Data Capture/related applications and industry standards.
    • Moderate technical skills in working with data from CROs and other third-party vendors.
    • Strong verbal/written communication skills, analytical skills, organizational skills, and interpersonal skills.
    • Ability to work effectively with people at different levels and from different disciplines and cultures.
    • Working knowledge of clinical operations and relevant regulatory requirements.
    • Experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic areas.
    • Moderate skills in continuous improvement, project management, change management, and risk management.

    Employer Statement: Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

     

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