PRAHS

  • Principal Lead Data Manager

    Job Locations (All) | Korea, South
    Posted Date 1 week ago(11/7/2018 12:28 AM)
    ID
    2018-50203
  • Overview

    Principal Lead Data Manager

    Location (Seoul, South Korea)

     

    As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and / or international regulatory approval of 45+ such drugs.

    At PRA Health Sciences, providing innovative solutions for our clients is what we do.  From full service clinical development to the pioneering Embedded Solutions model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

     

    At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

    Responsibilities

    PRA is pleased to announce we are hiring an experienced Principal Lead Data Manager to join our Strategic Solutions division.  This is an excellent opportunity for career development, be dedicated with a top pharmaceutical client and work as part of a team of global data managers.

     

    Duties will be:

    • Serving in a leadership role for Data Management issues with both internal client teams and Data Management CROs/Vendors
    • Oversight responsibilities for Data Management CRO for all of the DM activities and deliveries including protocol review, CRF design, EDC set-up, all documentation, external data handling, protocol deviation handling. SAE reconciliation, data QC, communication with study team and DM CRO, database lock and file archiving.
    • Focussing on Phase III-IV local interventional studies, Non-interventional studies, post Market Surveillance and Medical Affairs studies across multiple Therapeutic Areas
    • Tracking milestones and tasks for assigned projects
    • Ensuring timely completion of all project status reporting
    • Interfacing with team members across all departments as needed
    • Providing study specific, including protocol training, to extended Data Management team members as appropriate
    • Attending client kick off and investigator meetings as required
    • Ensure oversight QC steps are implemented so quality deliverables are provided
    • Ensuring project deliverables are achieved in terms of timelines and quality
    • Setting timelines for CRO/study team
    • Identifying and negating study issues early in the start-up process
    • Oversight of CRO performing hands on data management tasks from start-up through database lock
    • Providing system demonstrations as needed to study team members
    • External vendor management including creating Data Transfer Agreements

    Qualifications

    In order to be considered for the Principal Lead Data Manager role at PRA, you will need to have an undergraduate Life Science degree with demonstrable industry experience with most of the major Data Management study tasks.  

     

    Other skills required are:

    • 5 Years+ Clinical Data Management experience
    • Excellent written and oral communication skills.
    • Read, write and speak English
    • Proficiency in at least one EDC system required; preferably Medidata RAVE
    • Experience working in industry standard Clinical Data Management system(s)
    • Experience with all steps within the Data Management lifecycle
    • Experience as primary representative of Clinical Data Management project team
    • Proven history of successful interaction with internal and external clients and an understanding of related functions
    • Basic knowledge of CDISC/SDTM
    • Basic knowledge of SAS

    Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment.  As we continue to expand, there will be career opportunities on a truly global scale.


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

     

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