Covance

  • Lead Clinical Lab Data Manager

    Job Location(s) US-NC-Raleigh-Durham | US-NJ-Princeton | US-PA-Philadelphia | US-TX-Austin | US-IL-Chicago | US-MO-Kansas City | CA-ON-Toronto | CA-ON-Mississuaga
    Job Number
    2018-21944
    Job Category
    Other
    Position Type
    Full-Time
  • Job Overview

    Lead CDM (Specializing in Lab Data)

    Permanent, salaried

    Location: Remote (US or Canada)

     

    JOB SUMMARY

    Supervise all 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 Project Data Manager. Provide oversight to external suppliers such as EDC vendors.

    - Coordinate, create and maintain the Data Management Plan, Data Transfer Specifications, Data Validation Specifications, 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 and lead internal and external project meetings providing input from a lab 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 Chiltern or sponsor. Report and discuss findings with Project Data Manager and directly with other study team members.

    - 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 lab clinical data.

    - Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.

    - Gather and consolidate feedback, metrics and status reports from CDM Team Leads to assess CDA performance and quality of deliverables. Escalate any performance and quality issues to PDM.

    - Ensure company and departmental SOPs and standards are adhered to.

    - Provide feedback for performance evaluation and competency of Data Managers and assist with skill/career development for direct reports.

    - Be responsible for effective management of projects/sponsor groups, and assigned Data Managers (max. 4).

    - Present CDM function at conferences and external non-study meetings.

     

    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

       - Manage data transfer specifications, data mapping specifications to get the raw data into sponsor standard formats, lab data review and cleaning, lab data validation specifications

       -Lab experience; lab data managers liaise directly with many small laboratories and need to be able to effectively communicate with them. Knowledge of lab testing would be especially helpful

    - Manage and directly supervise assigned clinical data management team

    - 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. Six plus years experience in CDM or Biostatistics in a CRO or the pharmaceutical industry
    3. Experience in WFH setting and has shown independence and success in this setting
    4. Must be independently motivated, high productivity rate, assertive and vocal, confident in a study team position
    5. Biomarker experience or willingness to learn is a plus but not a requirement

     

    Education/Qualifications

    TRAINING AND EXPERIENCE

    1. Bachelor’s degree in Medical or Life Science, Mathematics or RN
    2. Six plus years experience in CDM or Biostatistics in a CRO or the pharmaceutical industry
    3. Experience in WFH setting and has shown independence and success in this setting
    4. Must be independently motivated, high productivity rate, assertive and vocal, confident in a study team position
    5. Biomarker experience or willingness to learn is a plus but not a requirement

    Experience

    TRAINING AND EXPERIENCE

    1. Bachelor’s degree in Medical or Life Science, Mathematics or RN
    2. Six plus years experience in CDM or Biostatistics in a CRO or the pharmaceutical industry
    3. Experience in WFH setting and has shown independence and success in this setting
    4. Must be independently motivated, high productivity rate, assertive and vocal, confident in a study team position
    5. Biomarker experience or willingness to learn is a plus but not a requirement

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