Covance

  • Clinical Data Manager

    Job Location(s) US-NC-Raleigh-Durham | US-PA-Philadelphia | US-TX-Austin | US-NJ-Princeton | US-MO-Kansas City | CA-ON-Toronto | CA-ON-Mississuaga
    Job Number
    2018-23947
    Job Category
    Clinical Data Management
    Position Type
    Full-Time
  • Job Overview

    Clinical Data Manager

    Permanent, salaried

    Location: Remote (US or Canada)

     

    JOB SUMMARY

    Hands on project data processing tasks. Work to departmental SOPs, guidelines and global standards to ensure data integrity.

     

    JOB RESPONSIBILITIES

    - Thorough understanding of Clinical Data Management tasks and assigned protocol(s) with ability to critically evaluate the information in relation to other key project documents and processes.

    - Monitor tasks vs. contractual obligations for CDM and report any out of scope items to the Lead Project Data Manager. Provide oversight to external suppliers such as EDC vendors.

    - Coordinate, create and maintain the Data Management Plan, eCRF Completion Guidelines and training materials. Work with KickStart and Sponsor on start-up activities. Sign off on documentation as required by SOPs and WPGs. Attend & present CDM materials at Investigator & CRA meetings.

    - Attend internal and external project meetings providing input from a CDM perspective. Ensure assigned actions are completed within the required timeframe.

    - Assist with tracking of project status, task completion, and staff productivity. Determine status of incoming data, site responsiveness, need for escalation for backlog to various functions within Theorem or sponsor. Report and discuss findings with Lead Project Data Manager.

    - Review and approve post production change control study documentation.

    - Ensure filing of study specific documentation as required by SOPs and WPGs and study needs. Maintain all data management study documents in the designated TrialShare area and PMF as required.

    - Provide reports to Sponsor and internal team as dictated by project need.

    - Be a resource to CDM team for questions and guidance as related to clinical data.

     

    KEY SKILLS & BEHAVIORS

    - Exemplify, deliver and expect professionalism using strong interpersonal and organizational skills

    - Keeps an internal and external client informed of project and/or technical issues by pro-actively communicating across teams/functions

    - Communicates effectively through both written and verbal methods

    - Anticipates changing priorities and demands and addresses them proactively

    - Manages time effectively in order to produce a quality deliverable in expected timeframe

    - Exemplify, deliver and expect professionalism using strong interpersonal and organizational skills

                                                   

    TRAINING AND EXPERIENCE

    1. Bachelor’s degree in Medical or Life Science, Mathematics or RN
    2. Five plus years experience in CDM in a CRO or the pharmaceutical industry
    3. Occasional Travel

                                                   

    Education/Qualifications

    TRAINING AND EXPERIENCE

    1. Bachelor’s degree in Medical or Life Science, Mathematics or RN
    2. Five plus years experience in CDM in a CRO or the pharmaceutical industry
    3. Occasional Travel

    Experience

    TRAINING AND EXPERIENCE

    1. Bachelor’s degree in Medical or Life Science, Mathematics or RN
    2. Five plus years experience in CDM in a CRO or the pharmaceutical industry
    3. Occasional Travel

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