• Medical Data Reviewer

    Job Locations (All) | Germany | Germany-Mannheim
    Posted Date 4 weeks ago(12/20/2018 3:15 AM)
  • Overview

    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 SolutionsTM 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 14,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.


    We have a new and exciting role within our Medical Affairs Dept, in our Mannheim office. The Medical Data Reviewer together with the Medical Director sets up and co-ordinates the medical data review process, assists with medical data review and manages medical queries. 


    The Medical Data Reviewer is required to have a close collaboration with various members of the Data Management team, most frequently but not limited to the Data Coordinator & Lead Data Manager, Biometrics Project Manager and Clinical Data Programmer.


    Specifically the Medical Data Reviewer reviews medical data for consistency and medical plausibility and to ensure that the data is comprehensive from a medical point of view across different studies and projects.

    Other responsibilities of the Medical Data Reviewer will include:

    • Authors the Medical Data Review Plan, under supervision of the MD, assuring consistency with other project plans, client contract, and PRA SOPs and procedures
    • Attends Investigator Meetings for large projects, as needed
    • together with the MD and Data Management, compiles the Medical Review Checklist
    • Reviews and develops the Standard and Customized Objects with Data Management
    • Raises and responds to medical queries, consulting with the MD as needed, having a general understanding of the protocol and other relevant study documents
    • Will acquire solid proficiency in various EDC systems, able to train others in the Medical team
    • Completes review of project DCF tracking as necessary
    • Reviews and responds to QC findings, as needed
    • Performs other tasks as directed by the MD or other Medical Affairs personnel, such as VP, Medical Affairs


    Successful candidates for the Medical Data Reviewer role will preferably bring previous experience within clinical research. Given the client-focused and fast-paced nature of our work, we are looking for a pro-active individual with a strong eye for detail. 


    Ideally, you will be a licensed healthcare professional (registered nurse etc) or be educated to degree level in life sciences. Familiarity with medical terminology, strong organisational abilities, and a proven ability to use MS Office are skills essential to success in this role. 


    Fluency in English is essential. 


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


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