ProSciento, Inc.

  • Clinical Data Manager

    Job Location US-CA-San Diego
    Posted Date 9 hours ago(12/18/2018 12:30 PM)
  • Overview

    Summary: The Clinical Data Manager (CDM), under the direction of the Director, Clinical Data Management, is responsible for the daily clinical data management operations of studies managed by ProSciento. The Clinical Data Manager will concentrate on good data management documentation practices and apply ProSciento procedures to provide excellent service to our sponsors. Higher level CDMs will also mentor lower level staff. Performs duties in accordance with company’s values, policies, and procedures.


    Essential Duties and Responsibilities will include the following. Other duties may be assigned at the company’s sole discretion.


    • Leads the process of Electronic Case Report Form (eCRF) development for a study. Designs and tests studies in ProSciento’s data management system.
    • Manages workload for 3 to 4 single-site and/or full scope CRO trials, or a combination of single or multiple site CRO projects.
    • Leads the development and maintenance of the Data Management Plan (DMP).
    • Creates study-specific data entry instructions and conventions.
    • Creates and maintains the data validation specifications.
    • Designs edit checks within the ProSciento data management system that conform to the data validation specifications.
    • Performs discrepancy management within the ProSciento data management system.
    • Routinely reviews data issues with internal site staff and assists Data Entry Associates with updates according to discrepancy responses to maintain a clean database.
    • Develops data listings and reports from the data management system and performs trend analysis to inform data review, using tools such as Smart Reports in the EDC.
    • Creates and maintains study status reports for tracking eCRF completion, discrepancy management, and other study metrics as needed.
    • Performs medical coding of adverse events and concomitant medications.
    • Manages and QCs data received from external vendors.
    • Prepares and QCs internally-generated data for review by CRAs or the project manager, and for transfer to clients.
    • Supports the Director, Clinical Data Management, in the oversight of CROs or third party vendors for any outsourced studies.
    • Attends team meetings as needed to represent CDM interests.
    • Reviews protocols and provides input relevant to data management issues.
    • Provides input for the development of project specific timelines and budgets.
    • Trains on department specific Standard Operating Procedures (SOPs) and Work Instructions (WIs).



    To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


    CDM Education and Experience:

    Bachelor’s degree in life sciences or mathematics and/or formal or on-the-job training in clinical trial methodology and Good Clinical Practice (GCP) plus three or more years of experience in direct data management experience at a CRO, pharmaceutical, or biotechnology company and/or an equivalent combination of education and experience. Experience writing data entry and training documentation.


    Skills, Knowledge, and Abilities:

    Technical competency using data management systems, especially EDC systems. Understanding of US and international regulatory mandates and guidance for clinical research including FDA/ICH-GCP. Demonstrated ability to manage a complex workload and prioritize tasks based on program goals. Ability to work quickly and independently and as a strong team player.


    Certificates and Licenses:

    Certificate in building EDC systems preferred.


    Language Skills:

    Ability to read and interpret documents such as SOP’s, WI’s, procedural manuals, governmental and clinical regulations, and similar documents. Excellent oral, written and interpersonal communication skills with the ability to communicate effectively to employees and Management groups and in group meeting settings.


    Math Ability:

    Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.


    Reasoning Ability:

    Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.


    Computer Skills:  To perform this job successfully, an individual should have intermediate knowledge of the current MS Office Suite.


    Work Environment:

    The work environment characteristics described here are representative of those an employee may encounter while performing the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


    The noise level in the work environment is usually quiet to moderate.


    Physical Demands:

    The physical demands described here are representative of those that must be met by an employee to successfully perform essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.


    The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close, distance and peripheral vision as well as depth perception and the ability to adjust focus. While performing the duties of this job the employee is regularly required to sit, talk and hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk, stoop, kneel, crouch, or crawl.


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