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    Project Manager - Data Management And Regulatory Use (Ru)

    Coalition Of Cancer Cooperative Groups
    5+ years
    Not Disclosed
    Philadelphia
    10 July 31, 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

    Position: Data Management Supervisor (Hybrid/Remote)

    Location: Center City, Philadelphia (Hybrid preferred, remote considered)

    Company: Coalition of Cancer Cooperative Groups

    About Us: The Coalition of Cancer Cooperative Groups is a unique nonprofit organization dedicated to improving patient awareness of cancer clinical trials, facilitating access, and promoting participation. Established in 1997, we work with National Cancer Institute-sponsored Cooperative Groups, leading patient advocacy organizations, and oncology specialists to streamline and promote cancer clinical trials.

    Position Overview: The Data Management Supervisor will assist in daily oversight, training, and resource allocation for the Data Management Staff, ensuring timely and efficient completion of tasks and projects. This role involves interacting with various Coalition functional areas and industry collaborators to support departmental and company needs.

    Key Responsibilities:

    • Oversee and manage data management staff, providing daily guidance and support.
    • Develop and maintain SOPs and work instructions related to data management and regulatory use.
    • Mentor and train data management staff.
    • Act as a liaison to industry sponsors and Medidata Rave for data management deliverables and initiatives.
    • Assist with study building, ensuring effective communication with study builders for updates.
    • Develop and review a standard library of CRFs, edit checks, and custom functions.
    • Serve as a Subject Matter Expert (SME) for CDASH/CDISC compliance and SDTM mapping.
    • Oversee the implementation of clinical study databases into production.
    • Manage projects and assign tasks as needed.
    • Provide input to the Senior Director on process improvements and new procedures.
    • Maintain all Data Management department SOPs and related documentation.
    • Act as the primary contact for the department in the absence of the Senior Director.
    • Participate in required meetings and conference calls, including industry collaborations.
    • Review contracts and scopes of work for industry collaborations.
    • Liaise with the Senior Director, Clinical Research, and industry collaborators to ensure delivery of data management contract deliverables.
    • Develop and present data management presentations.
    • Assist with the department’s hiring process and training needs assessment.
    • Participate in performance reviews of junior staff.
    • Manage multiple priorities and adjust workloads as necessary.
    • Provide feedback in a constructive and diplomatic manner.
    • Maintain objectivity when evaluating the work of colleagues.
    • Undertake special projects as assigned by the Senior Director, Clinical Research.

    Qualifications:

    • Minimum of 5 years of experience in data management for clinical research trials, specifically in oncology.
    • Experience in data management within a pharmaceutical company or CRO.
    • Strong understanding of data collection and management practices for oncology clinical trials.
    • Extensive experience with Medidata Rave.
    • Familiarity with regulatory data management practices, including global experience, is preferred.
    • Bachelor's degree from an accredited institution or equivalent professional experience.
    • Medidata certifications in data management.

    Benefits: Join a mission-driven organization dedicated to advancing cancer research through innovative programs and services. This position offers a competitive salary and benefits package, including medical, dental, and vision insurance, disability and life insurance, a 401(k) plan, paid vacation and holidays, and opportunities for professional growth.

    If you are passionate about making a difference in cancer research and meet the qualifications, we encourage you to apply and join our team in our mission to improve patient awareness and participation in cancer clinical trials.

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