PRAHS

  • Trial Manager - Early Development - Oncology (Home-Based)

    Job Locations (All) | US-Remote
    Posted Date 2 weeks ago(10/9/2018 11:06 AM)
    ID
    2018-49650
  • 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 15,000 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

    The Early Development & Clinical Pharmacology (ED&CP) Trial Manager is responsible for the local management of a trial in one or more countries and to deliver quality data and trial documents/records that are compliant with assigned clinical protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Health Care Compliance requirements (HCC) and local regulatory requirements.

     

    He/she acts as the primary point of contact at a country level for assigned studies.

     

    The TM performs the Local Trial Manager (LTM) tasks including operational oversight of assigned protocol(s) from start-up to database lock and closeout activities as described in GCO procedural documents.

     

    The TM performs the Trial Leader tasks as described for ED&CP studies which follow the ED&CP hybrid oversight model.

     

    The TM may perform the Site Manager (SM) tasks as described in procedural documents for ED&CP studies.

     

    The Sr. TM actively contributes to process improvement initiatives, training and mentoring of TMs, SMs and Clinical Trial Assistants (CTA).

     

    Compared to a TM I, a Senior TM is often assigned to multi-center complex protocols and can work across Phase 0 – IIa studies in multiple therapeutic areas as needed to drive business needs. This role is likely to focus in Oncology.

    Qualifications

     

    • 3+ years of clinical research experience required
    • Read, write and speak fluent English; fluent in host country language required.
    • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
    • 2+ years of Clinical Trial Management experience PREFERRED;  4 years' experience with trial management highly preferred
    • Experience in mentoring/coaching and providing training to Site Managers/Trial Associates, leading a team/initiatives - Highly preferred
    • Experience with Early Development studies HIGHLY PREFERRED
    • Experience with Oncology studies HIGHLY PREFERRED
    • Willingness to travel with occasional/regular overnight stays may be required
    • 2+ years monitoring experience preferred


    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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