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Horsham

    Specialist 3 - Horsham, United States - Pioneer Data Systems

    Pioneer Data Systems
    Pioneer Data Systems Horsham, United States

    1 week ago

    Pioneer Data Systems background
    Description

    Position Details:

    Our client, a world-leading Pharmaceutical Company in Horsham, PA is currently looking for a Clinical Data Specialist to join their expanding team.


    Job Title:
    Clinical Data Specialist / Medidata Rave / Hybrid Work

    Duration: 6 months contract, extendable up to 24 months


    Location:
    Horsham, PA

    Hybrid Work: 2-3 days/week onsite


    Note:

    The client has the
    right-to-hire you as a permanent employee at any time during or after the end of the contract.


    You may participate in the company group medical insurance plan


    Job Description
    Company is recruiting for a contract Medical Reviewer, located in Horsham, PA, USA, hybrid in-office and remote.

    The Medical Reviewer will assist the CARVYKTI Medical Affairs team in finalizing data reconciliation in a post-marketing clinical trial for patients who have received CARVYKI.

    The duration of this temporary, contract position will last approximately 6 months in 2024.


    Key Responsibilities:
    Using RAVE and the iDARTs systems, identify, query, and resolve discrepancies in clinical trials

    Collaborate with the study responsible physician, other medical reviewers, the program manager, and other Company study personnel to address issues and status related to the completion of medical review activities

    Generate reports and communicate findings during routine team meetings

    Support the study team during presentations to leadership

    Support the development of the Clinical Study Report (CSR); activities may include authoring some content and managing the workflow of content development

    Support the team with other activities related to the study


    Qualifications Education:
    Bachelor's degree required

    MD/DO, PhD, or PharmD preferred


    Experience and Skills:
    Required:

    Experience with reconciliation of clinical trial data

    Experience with RAVE and iDARTs datbases


    Oncology experience Preferred:
    Experience working on hematology/oncology clinical trials

    Experience in multiple myeloma

    CAR-T therapy experience or knowledge

    Medical Affairs acumen


    Prior experience collaborating in a team environment Other:
    English fluency

    Remote or hybrid workplace may be acceptable

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