• Clinical Data Manager

    Job Locations US-IL-Chicago
    ID
    2019-1130
    Category
    Clinical Development
    Type
    Full-Time
  • Overview

    Manages all aspects of clinical database design and reporting. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data. Standardizes data management procedures and documents for departmental operating procedures. Provides input to strategic decisions that affect the department. May give input into developing the budget.

    Responsibilities

    • Prepare data analysis listings and activity, performance, or progress reports, analyzing clinical data using the appropriate statistical tools.
    • Process clinical data including receipt, entry, verification, or filing of information.
    • Prepare appropriate formatting to datasets.
    • Design and validate clinical databases including testing logic checks.
    • Design forms for receiving, processing, or tracking data.
    • Develop or select specific software programs for various research scenarios.
    • Write work instruction manuals, data capture guidelines, or standard operating procedures. Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.
    • Develop technical specifications for data management programming and communicate needs to information technology staff.
    • Evaluate processes and technologies, and suggest revisions to increase productivity and efficiency.
    • Track the flow of work forms including in-house data flow or electronic forms transfer.
    • Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices.
    • Provide support and information to functional areas such as marketing, clinical monitoring, and medical affairs. Resolve escalated issues, as needed.
    • Conduct User Acceptance Testing and report feedback; track until resolution.
    • Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.
    • Monitor work productivity or quality to ensure compliance with standard operating procedures.
    • Generate data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems.
    • Confer with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols.
    • Develop project-specific data management plans that address areas such as data coding, reporting, transfer, database locks, or workflow processes.

    Qualifications

    • Bachelor's degree, or 5 or more years of experience in clinical data management.
    • Pharmaceutical development experience.
    • Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP).
    • Understanding of the tools of the trade, such as current good clinical data standards.
    • Understanding of multiple disease areas
    • Understanding of clinical and laboratory data
    • Competencies: Critical Thinking, Time Management, Complex Problem Solving, Independent Judgement, Analytical skills, Collaboration / Teamwork, Written and Verbal Communication skills
    • Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.

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