• Clinical Data Manager

    Job Locations US-MA-Bedford
    Posted Date 2 months ago(2 months ago)
    Job ID
    2018-1082
    # of Openings
    1
    Category
    Clinical
  • Overview

    As a member of the Clinical Data Management team leading the data management effort for multiple studies, primary responsibilities include CRF design, generating Data Management Plans, Data Review guidelines, Discrepancy management, training site and internal clinical team on EDC/other database tools, and data quality assurance on multiple studies. This individual represents data management within the clinical team, provides input on protocols, and overall data summaries etc. to management.

    Responsibilities

    • Responsible for the clinical data management activities for the entire life cycle of multiple clinical trials, from protocol concept review through completion of the Clinical Study Report.  Accountable for ensuring data quality and timeliness of study deliverables
    • Represent Data Management within Clinical Affairs Team
    • Responsible for CRF design per protocol requirements
    • Create and maintain the Data Management Plan and other study specific plans for multiple studies
    • Define data handling conventions, edit checks, quality acceptance and auditing criteria for electronic data as well as procedures for handling exceptions
    • Works closely with other data management team members to coordinate database live activities; programmer testing, data management testing and user acceptance testing for paper and EDC studies
    • Present CRF completion guidelines and study related data management processes at Investigator / kick-off meetings and trainings
    • Liaison between Clinical Project Managers, Field Monitors, Data Specialist and Database Programmer to resolve any data entry / data management issues
    • Uses available tools, systems and processes in support of the coding of medical terms
    • Coordinate interim and final database audits according to database QC plan
    • Coordinate database lock activities
    • Participate in the development and maintenance of Standard Operating Procedures related to data management activities
    • Create standard and ad hoc reports with the help of Clinical Database programmer

    Qualifications

    • Bachelor’s degree in health profession, science and/or engineering field
    • Eight plus years of experience in the medical device or pharmaceutical industry with a minimum of six years of experience in data management
    • Strong knowledge of SOPs, GCP standards and clinical data management systems
    • Experience with EDC systems such as iMedNet, OC-RDC or others
    • Excellent written and oral communication skills
    • Excellent organizational skills and attention to detail
    • Ability to prioritize and multitask is required

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