ERT

  • Clinical Data Manager

    Job Location US-NY-Rochester
    Shift
    Full-time/Regular
    Type
    Regular Full-Time
  • Overview

    Looking for varied and interesting work, working with a fun team in a fantastic environment? Join us in our Rochester, NY office as Data Manager in our growing Data Management team.

     

    Does Data speak to you? Are you captivated with the many insights that Data can bring to business decisions? As Data Manager you will be responsible for ensuring the highest quality data is obtained, processed and reported to our Study Sponsors!  In the DM role, you will also help define the methods and tools ERT uses to provide these services.

     

    Our Data Manager is the primary contact for all data-related study issues for both internal and external teams, so strong client-facing skills will be important to your success.

     

     

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    ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.


    Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.

     

    Responsibilities

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

    1. Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns including, but not limited to Data collection, Data cleaning, Data delivery, Data reconciliation, Database lock and Data Management activity timelines
    2. Define the Data Management Plan (DMP), in collaboration with study Sponsors to define study requirements and Query guidelines
    3. Work with internal teams on study setup requirements such as demographic collection and visit schedule requirements. Maintain good communications with related teams
    4. Lead the development, review, and finalization of data transfer requirements
    5. Serve as primary point of contact for query escalation
      • Routinely review and resolve escalated queries
      • Provide consolidated escalated query listings to Sponsor teams
    6. Prepare study database for archiving for Sponsors and sites
    7. Ensure high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times.
    8. Identify out of scope requests and elevate these requests to the Project Manager so that they can be properly billed through the Change Order process.
    9. Maintain Data Management Files
    10. Conduct routine status meetings with Sponsor/CRO and internal teams

     OTHER DUTIES AND RESPONSIBILITIES:

    1. Communicate project status clearly with Sponsors and Project Management
    2. Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation
    3. Lead in CAPA issues related to study-specific data management activities
    4. Process at least one routine data run per assigned study per quarter and perform all sample, complete and final data sends
    5. Assist in the preparation of monthly reporting by providing metrics as required

     

    The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.

     

    Qualifications

    1. BS/BA Degree in Life Sciences or related field preferred
    2. Minimum of 2 years Data Management or related experience preferably in a clinical research position. Strong client-facing skills/experience critical to this role. Formal project management experience strongly preferred.
    3. Strong knowledge of CDISC standards. Previous SAS or SQL exposure or experience strongly preferred
    4. CCDM certification very helpful/preferred
    5. Strong organizational, interpersonal, time-management, and problem-solving skills
    6. Ability to manage multiple priorities
    7. Strong attention to detail
    8. Proficient in Microsoft Office applications
    9. Ability to communicate effectively in English

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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