• Principal Lead Clinical Data Manager- REMOTE

    Job Locations (All) | US-Remote
    Posted Date 2 weeks ago(1/7/2019 8:34 PM)
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it?


    Because we’re hoping you’re here for the latter.


    Who are we?

    We Are PRA.


    We are over 15,000 employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.


    Who are you?

    You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Lead Data Manager, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.


    Still here? Good. Because if this is you, we’d really like to meet you.


    What will you be doing?



    As a Principal Lead Clinical Data Manager, you will oversee the data management strategy and project plans for collection and integration of all clinical data including but not limited to, case report forms (CRF) data, lab data, biomarker data, and patient reported outcomes for one or more trials within a specific drug program.  You will lead cross-functional, global teams to ensure all aspects of the project plan (from data management trial planning through submission components) are executed on time and with appropriate quality.  You will serve as a project manager for data management activities and represent global data management for assigned trials.


    What do you need to have?


    Education: Bachelor’s degree preferred

    Experience:  7 years of data management experience preferred



    • Manage all operational aspects of clinical trials in compliance with GCP regulations, PRAHS policy and Client Company policy.
    • Manage project and timelines across Client programs and studies.
    • Ensure timeliness of deliverables for each phase of the study from study start-up through production and close-out activities.
    • Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Safety, Medical Coding, site personnel.
    • Ensure Clinical Data Management staff maintains all relevant documentation associated with each assigned Protocol.
    • Identify and work collaboratively and cross-functionally to implement process improvement measures within data management on both departmental and project level.
    • Coordinate with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion.
    • Lead study/project team meetings as primary facilitator of timelines, providing updates on study status to the cross functional team.
    • Escalate any potential or actual issues in a timely manner and follow issues through to resolution.
    • Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.
    • Serve as primary point of contact for all project timeline related communication.
    • Monitor and work to maintain/improve stakeholder satisfaction by ensuring high quality service, communication, and management of clinical data.
    • Lead and facilitate all project team meetings.


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


    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.


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