Advanced Group

  • Clinical Data Manager

    Job Locations US-Nationwide
    Req No.
    2018-9901
    Type
    Regular Full-Time
    Client
    Advanced Clinical
  • Overview

    Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

     

    A Clinical Data Manager is responsible for the quality and accuracy of the database for a clinical study.  Their duties include 1st and 2nd pass entry of Case Report Forms (CRFs) and Data Clarification Forms (DCFs), Quality Control (QC) checks, Data Management Review (DM Review) and creation of study documents. 

    Responsibilities

    • Follow Standard Operating Procedures (SOPs)
    • Perform QC checks using applicable browser or reporting tools
    • Participate in client study kickoff and closeout meetings
    • Create materials for and, if necessary, conduct internal kick-off meetings
    • Create materials for and, if necessary, conduct regularly scheduled meetings with the client
    • Prepare Study Set-up
      • Review draft CRFs/Electronic Case Report Forms (eCRFs)
      • Prepare draft of CRF/eCRF Completion Guidelines
      • Prepare draft of Data Management Plan (DMP) and Data Cleaning Plan (DCP)
      • Perform User Acceptance Testing on the database
        • Create and enter test data
        • Document findings and provide them to applicable personnel
      • Perform User Acceptance Testing on edit checks
        • Create and enter test data
        • Review resulting discrepancies to ensure edit checks are working properly
        • Ensure edit check wording is accurate and matches the DCP
        • Document findings and provide them to the applicable personnel
    • Perform DM Review
      • Perform discrepancy management by effectively utilizing the DMP and DCP
      • Perform manual review as listed in the DCP
        • Identify data discrepancies outside of the DCP and create manual queries where necessary
        • Communicate potential issues to applicable data management personnel and/or the client
      • Perform vendor data reconciliation with applicable clinical database (e.g., IVRS, laboratory data)
        • Issue queries, if applicable
        • Communicate findings to applicable personnel
      • Perform query processing and entry
      • Perform query creation, printing, and resolution, if applicable.
      • Track all DM issues and ensure proper resolution by study completion
      • Identify data trends and report inconsistencies to applicable data management personnel and work together to develop and implement an action plan
      • Review data for overall consistency and accuracy of data entry, query resolution and DM Review
      • Review study reports for accuracy and consistency
      • Communicate with client representatives, if necessary
      • Communicate with the programming team regarding any database or programming changes needed throughout the study, when applicable
    • Assist with final QC reviews and data listing audits
    • Maintain and compile all study documentation
    • Perform steps pertaining to database freeze/lock and coordinate all related activities

    Additional Responsibilities:

    • Perform 1st and 2nd Pass entry following the DP and client conventions
    • Assist in the creation and review of SOPs and training materials
    • Ad hoc report creation
    • Assist in training employees
    • Interview job applicants and provide feedback
    • Perform other duties as required by management

     

    Qualifications

     A Bachelor’s degree or Associate’s degree with at least 2 years of experience in clinical research and/or management approval/recommendation is required.  At minimum, this should include 1 year of data management experience, including a basic understanding of the elements of database creation.  The candidate must have excellent written, verbal and organizational skills.  They must also be detail-oriented, a self-motivator, and proficient in the following:  query processing, QC Review, and DM Review.  The candidate must be willing to take on additional projects and work overtime when necessary. 

     

    Minimum Training Requirements

    The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:

    • Applicable Standard Operating Procedures
    • Good Clinical Practices (GCP Regulations; ICH Guidelines; Good Quality Practices)
    • 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used In Clinical Trials)
    • Good Clinical Data Management Practices
    • HIPAA
    • Drug Development and Approval Process
    • Data Management Overview
    • Sponsor/Study specific trainings, when applicable
    • Applicable system training

    What’s in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:

    Our Culture: https://careers.advancedgroup.com/embrace-our-culture

    Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential

    Community Programs: https://careers.advancedgroup.com/unleash-your-passion

    For a complete list of all of our job openings, please visit Advanced Group’s career site here.

     

    It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.


    This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job.  If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

     

     

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