Advanced Clinical

  • Manager of Data Management

    Job Locations US-Nationwide
    Req No.
    2018-9082
    Category
    Biotech/R&D/Science
    Type
    Regular Full-Time
  • Overview

    A Manager of Data Management is responsible for managing the activities of data management studies and staff in a manner that ensures all time frames and targets are met to the client's satisfaction. A Manager of Data Management may oversee all phases of studies for multiple studies across multiple clients and compounds. 

     

    In addition to their managerial duties, a Manager of Data Management may also have data management responsibilities for one or more studies. 

    Responsibilities

    Managerial Responsibilities:

    • Train, mentor, monitor, and supervise direct reports (including reviewing training files and monitoring time reporting)
    • Coordinate teams and assign resources and projects to ensure all timelines are adequately met
    • Ensure overall quality and quantity of DM activities
    • Conduct APMS evaluations for direct reports, including guidance toward reaching organizational and career goals
    • Escalate study status and/or employee issues, as necessary
    • Create and verify accuracy and completion of monthly billing reports
    • Understand the Advanced Group of Companies' (AGC) financial plan and Advanced Clinical's (AC) contribution to and support of AGC's financial goals 
    • Maximize productivity of direct reports to exceed AC's revenue goals
    • Create training and establish training programs for new processes
    • Identify possible improvements to current processes, determine new processes that are needed, and initiate a plan to improve or develop processes
    • Standard Operating Procedures
      • Be familiar with and follow department SOPs
      • Ensure staff is adequately trained on and follow all applicable SOPs
      • Create, revise and review SOPs to recognize and prevent potential regulatory issues
    • Interview job applicants and provide feedback to upper management 
    • Other global management responsibilities as requested

    Data Management Responsibilities: 

    • Creation, review and/or approval of study items including, but not limited to: 
      • Project Management Plan (PMP)
      • Study/Global Conventions 
      • Data Management Plan (DMP)
      • Data Cleaning Plan (DCP)
      • Case Report Forms/Electronic Case Report Forms (CRFs/eCRFs)
      • CRF/eCRF Completion Guidelines
      • Database Specifications/Annotated Case Report Forms 
      • Derivation Programming/Testing
      • Validation Programming/Testing
      • Database User Acceptance Testing (UAT)
    • Ensure study tasks are being completed accurately, consistently and within the agreed upon timelines 
    • Perform steps pertaining to database freeze/lock/release and coordinate all related activities
    • Act as the main point of contact for client communication 
    • Conduct, participate in and/or organize study kick off and lessons learned meetings 
    • Create materials for and conduct regularly scheduled meetings with the client 

    Additional Responsibilities: 

    • Perform 1st and 2n Pass entry following the DMP and client conventions 
    • Perform DM Review
    • Perform Quality Control (QC) reviews/checks using the applicable browser tool 
    • Maintain a membership in an industry-related society or professional organization
    • Have a basic knowledge of the elements of database creation 
    • Possess at least intermediate skills for all Microsoft Office programs 

    Qualifications

    • Bachelor's degree
    • 5+ years of experience in data management with a minimum of 2 years at Advanced Clinical and/or management recommendation is required
    • Must possess a full understanding of all aspects of data management
    • Must have excellent written, verbal and organizational skills 
    • Must be detail-oriented, a self-motivator
    • Proficient in the following: 
      • 1st and 2nd pass entry
      • query processing
      • QC Reviews
      • Data Management Review
    • 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 (Pat 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 
    • MedDRA and WHODrug Overview 
    • CRF Creation Overview 
    • Data Management Plan Creation
    • Sponsor/Study specific trainings, when applicable
    • Applicable system training 

    For a complete list of all of our job openings, please click 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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