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    Manager, Data Management - Cambridge, United States - SRG Talent

    SRG Talent
    SRG Talent Cambridge, United States

    2 weeks ago

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    Description

    Job Title:
    Manager, Clinical Data ManagementLocation: Cambridge, MaWorksite: On-site M-F, Potential Hybrid

    Job Type:

    Full-Time permanentWe are searching for a full-time Manager of Clinical Data Management for a Global Pharmaceutical CRO located in Cambridge, Mass.

    This role is responsible for managing and supervising a team of Clinical Data Managers (CDMs). Oversee each project assigned to the team.

    Responsibilities include, but are not limited to:
    QC each deliverable prior to sending to internal or external clientsPrepare and present individual performance reviewsProvide mentorship to DM staff and suggest/implement solutions for complex issuesAssist staff with interactions with sponsors and managing vendorsKeep supervisor updated on study progress and staff management through routine meetingsMaintain a positive, progressive, and proactive management style and communicationDevelop and update data management SOPs and training manualsConduct data management training as well as study specific training for the CDM and study teamsProvide input from the data management perspective regarding the design of clinical trial protocolsOversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock ProceduresOversee and participate in the process of data review and query generation proceduresOversee and participate in the coding of medical termsOversee/define/perform SAE reconciliation processesWork with DM leads and DB programmers to design (e)CRFs and edit checks in EDC systemEnsure proper completion of UAT of EDC system and modulesOversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation


    WHAT YOU NEED TO HAVE:

    Minimum BS in a scientific or health related field or equivalentMinimum of 10 years of experience in Clinical Data ManagementMinimum of 2 years supervisory experience is requiredKnowledge of GCPs and regulatory agency guidelinesFamiliarity with medical terminology is requiredSkilled in the use of data management software application, Medidata RAVE** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

    SRG is an Equal Opportunity Employer.

    All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

    Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion.

    All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

    If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR- or fill out this form to request accommodations.

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