• Operational Study Manager - Real World Solutions and Late Phase Services

    Job Locations (All) | US-PA-Blue Bell | US-Remote
    Posted Date 1 month ago(1/18/2019 9:36 AM)
  • Overview

    Operational Study Manager – Real World Solutions

    Location – Blue Bell, PA or Remote US


    The fundamental focus of this role is to manage study teams on a variety of Real World Solutions projects and achieve successful delivery of operational activities (site management, clinical monitoring and data review) by meeting internal and external client requirements.


    Key Responsibilities:


    Working on different global studies for the full project lifecycle, your key responsibilities will include:

    • To manage all study site related activities
    • To assume responsibility for project planning, set-up and conduct, communication and reporting and training of the study team
    • To supervise the site recruitment and patient-enrolment stages of the study
    • To liaise with the client for all site related issues, progress and risk
    • To create study tools and dashboards (specifically related to study status and site performance), to create project documents and templates including training materials
    • To plan on-site visits as required
    • To lead the study team of Site Management Associates and Clinical Research Associates across a region
    • To review and approve monitoring visit reports
    • To manage the operational budget, identify out of scope tasks and escalate as required
    • To manage and forecast resource needs to ensure project profitability
    • To collaborate with colleagues in our Biometrics department for delivery of data management deliverables, to oversee the clinical data review process and ensure quality control steps are planned and completed
    • Contribute to business development activities by participating in proposals and bid defenses when required



    • Client management experience, including strong presentation skills and ability to speak to all aspects of clinical operations at project level
    • A robust knowledge of clinical research, preferably inclusive of Real World/Phase III, including study designs, GxP regulations and technologies / approaches associated with data management
    • 3+ years clinical research experience including site monitoring and/or management of study sites and clinical operations through the full project lifecycle
    • Experience leading professional staff in a clinical research environment
    • Read, write and speak fluent English
    • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution required

    Must Haves:

    • Client management, team leadership, knowledge of and experience in clinical research.

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


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