PRAHS

  • Lead Data Manager

    Job Locations - | US-PA-Blue Bell
    Posted Date 2 weeks ago(7/10/2018 11:01 AM)
    ID
    2018-47853
  • Overview

    This is a professional individual contributor role that provides oversight and accountability for more than one low to moderate complexity trial or one high complexity trial. May be a member of more than one project of low to moderate complexity or member of one project of high complexity.

     

    This position requires In-depth knowledge of the protocol. In-depth knowledge of current clinical drug development processes is needed. In-depth knowledge of applicable international guidelines regarding data management of clinical trials is required. This position needs to understand relevant system/technical knowledge. In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) is required. Knowledge of technology platforms, confidentiality for data exchange, and project management and techniques is required.

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    Responsibilities

    • Takes a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
    • With the trial customer, CRO and other functional partners:
    • Gathers content and integration requirements for eCRF and other data collection tools.
    • Establishes conventions and quality expectations for clinical data.
    • Establishes expectations for dataset content and structure.
    • Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.
    • Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction.
    • Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
    • Ensures real-time inspection readiness of all IDS deliverables for the trial; Participate in Regulatory Agency and internal audits as necessary.
    • Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.

    • Takes a leadership role with the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met.

    • Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.

    • Identifies and participates in process, system, and tool improvement initiatives within IDS.

    • Presents and trains at investigator and monitor meetings.

    Qualifications

    • Bachelors degree or professional experience equivalent.
    • Data management experience.
    • Experience in clinical drug development within the pharmaceutical industry or related industry.
    • Vendor oversight experience.
    • Team leadership experience.
    • Project management experience.
    • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.




    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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