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

    Job Locations (All) | US-Remote | US-PA-Blue Bell | US-CA
    Posted Date 2 weeks ago(10/9/2018 9:05 AM)
  • Overview

    Operational Study Manager – Real World Solutions

    Location – Blue Bell, PA or Remote US


    Achieves successful delivery of operational activities (site management, clinical monitoring, and/or data review) by meeting internal and external client requirements. Oversees the management of physician sites to ensure compliance with the protocol, ICH-GCP, other relevant guidelines (such as ISPE GPP) and applicable regulations, as well as SOPs. Contributes to Business Development Activities by participating in proposals and bid defenses as required.   Along with the OSM (Operational Study Manager) role on a project, may function in a PM role with mentoring and supervision.  


    Key Responsibilities:

    • Manages all study site related activities in a project including
    • Project Planning, Set Up and Conduct, Communication and Reporting, Training and Oversight
    • Plans for all activities in a project related to investigational sites and generates the related planning documents depending on the scope of work (including but not limited to Study Start-up Plan and Site Management Plan).
    • Serves as primary liaison for the client for all clinical operations issues, including but not limited to site management and applicable clinical monitoring issues, escalating as required.
    • Defines and provides project-specific training for the site management and regional monitoring team and ensures relevant training is completed before the team members start on a specified task.
    • Leads the site management and regional monitoring team on a project, providing oversight and mentoring as required.
    • Supervises patient enrollment/registration, study data review, and query resolution efforts.
    • Reviews and approves monitoring visit reports and ensures tracking and resolution of ongoing site issues.
    • Manages the operational budget and identifies out of scope tasks from the operational team and escalates as required.
    • Collaborates with Clinical Informatics in achieving successful delivery of data management deliverables, meeting internal and external client needs:provides day-to-day oversight of the clinical data review process during study conduc
    • Reviews and provides input on data management plans for content and structure
    • Contributes to Business Development activities, participating in proposals and bid defenses as needed.




    • Ability to understand the big picture – the scientific goal of their project, how the study design relates to that, why the client is doing the research, what the regulatory requirements will be for a particular study (in late phase, this does vary more than in PR), independent problem solving to make sure timelines are met, assessing risk at the project and also site level, prioritization to meet client needs and deliverables. The OSM needs to also understand how the smaller site-level tasks that the SMAs are doing fit into this big picture.
    • The OSM role is client-facing so we need someone with solid experience who will be able to handle demanding clients. We need the clients to feel like they have confidence that they’re in good and experienced hands, someone who has experience in a variety of therapeutic areas/study designs in late phase is ideal.
    • Strong leadership skills as they lead the SMA team – approachable enough to encourage them to escalate issues and be a mentor but, again, strong enough to keep them on track and accountable.
    • Good, polished presentation skills (delivering a presentation is part of the interview) – they will need to participate in bid defense meetings and regularly present progress updates in client meetings and they can’t get rattled by tough questions.
    • Data management experience is also an important asset for OSMs to have. This is an important element of the role and really, what our clients are looking for in the end is clean data of high quality.
    • 3+ years clinical research experience including site monitoring and management of study sites from start-up through close-out
    • Experience leading professional staff in a clinical research environment
    • Proven skills with electronic data capture software
    • Read, write and speak fluent English
    • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution required

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


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