• Data Reviewer

    Job Locations US-PA-Plymouth Meeting, PA. USA
    Job ID
    2018-2971
    Category
    Administrative/Clerical
    Position Type
    Permanent Employee - Full-Time
  • Position Summary

    Data Reviewer - Plymouth Meeting

      

    The Data Reviewer will work closely with the Data Manager or designee in order to have a comprehensive understanding of the trials supported and collaborate on the data cleaning and monitoring activities needed based on the Data Management Plan (DMP). Furthermore, the Data Reviewer must be able to identify effective ad hoc monitoring solutions in response to new or emergent scenarios while maintaining the quality and integrity of the data. Therefore, an ideal candidate will demonstrate a strong analytical and rigorous thought process. All changes to the eCOA database are managed in line with the company’s quality management system and supported by the appropriate study documentation to guarantee compliance with regulatory authorities and/or the company’s Sponsors.


    This position will interact daily with the Data Manager and Project Delivery resources of the company.

    Responsibilities

    • Monitor and clean data based on the Data Management Plan (DMP) utilizing the reports and tools provided.
    • Effectively enter Data Clarification Forms (DCF) based on data cleaning efforts.
    • Manage, analyze, and verify DCFs submitted through the TrialManager® for studies as assigned.
    • Implement assigned project timelines and prioritization of tasks pertaining to the Data Management services.
    • Assist in the resolution and response to issues and questions from client study team, physicians and site staff for data monitoring activities
    • Develop and Maintain study-specific documentation manuals including but not limited to the Maintenance Guide (MG) appendix as needed to support the Data Management Plan
    • Ongoing knowledge of study activities, protocol updates, data requirements and relationships to facilitate DCF verification
    • Train new team members within the Data Management and Data Reconciliation teams in performing day to day tasks as part of their roles.
    • Assist the Data Manager in development of study specific Data Management Plans as required by the client
    • Assisting the Data Manager in the application and interpretation of data to drive quality improvement efforts
    • Collaborate with internal and external resources to ensure consistency of methods, interpretation and approach
    • Supports delivery of improvements in the Data Management process by participating in small group activities, kaizen events and Lean Six Sigma projects when necessary
    • Other responsibilities will be assigned as required.

    Requirements

    • Minimum education: Bachelor’s degree in Science related field or related/equivalent experience.
    • Ability to operate within cross-cultural, multi-disciplinary teams and therapeutic areas
    • Experience with Electronic Data Capture and/or other data management services.
    • Experienced in Extracting, reviewing, analyzing and producing valuable insight to users
    • Ability to multi-task and effectively set own priorities.
    • Must have excellent communication and written skills.
    • Must have MS Tool experience (Intermediate) – Word, Excel, with MS Project, PowerPoint.
    • Must be able to communicate effectively with Delivery Teams, internal and external Data Management and Clients.
    • Must be a team oriented person with a “can do” attitude.

     

    CRF Health aspires to be the market leading provider of patient centred eSource technology and service solutions focused on flexibility and innovation, underpinned by deep regulatory and technical knowledge and high-quality service delivery.
     
    We have operations in Finland, the US, Romania and the UK and continue to grow in terms of revenues, customer numbers and employees.
     
    CRF Health creates electronic Clinical Outcome Assessment (eCOA) solutions that are simple, scalable, and effective. From our collaborative, agile design approach to our user-friendly reporting tools, we streamline complex processes and deliver reliable results for superior clinical trial outcomes. We improve patient engagement with intuitive design, support study teams with tailored scientific insights, and secure high-quality data with precision. Above all, we ease the path to approval.
     
    Our personalized service and unparalleled eCOA expertise helps sponsors bring new medicine to market quickly and cost-effectively, improving lives across the world.  More information on CRF Health to be found at www.crfhealth.com


    If this role isn't quite right for you then click here and search on all our current vacancies.

    The "Behaviours" we will measure you against - the "how you do it" - includes:

    • Embrace Collaboration
    • Own Your Contribution
    • Drive for Results and
    • Passion for the Customer


    How do the decisions in the design and analysis of mode equivalence studies affect study outcomes? Learn more

     

     

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