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Somerville

    Manager, Clinical Document Management - Somerville, United States - bluebird bio

    bluebird bio
    bluebird bio Somerville, United States

    4 weeks ago

    Default job background
    Description

    HOW YOU'LL FLY
    You'll help to bring more patients their bluebird days by:


    Oversee eTMF (electronic Trial Master File) creation, maintenance, and archiving, ensuring each are performed in accordance with Standard Operating Procedures (SOP), ICH-GCP Guidelines, EMA, FDA, and other appropriate regulations.

    Contribute to the integrity, completeness, and accuracy of bluebird bio's eTMF. Continuously work in a team environment, including meeting deadlines, prioritizing, and balancing work and projects from multiple sources. Collaborate with Associate Director and Director on projects as needed. Position reports into the Somerville, MA office; however, telecommuting from a home office is allowed.


    WHAT YOU'LL BRING
    You're the bird we're looking for if you have:


    Requires a bachelor's in biomedical, Healthcare Informatics, Life Science, Project Management, or a directly related field plus 4 years of experience as an eTMF Manager or other occupation/position/job title involving clinical study records management and maintenance of TMF/eTMF.


    Experience may be gained concurrently and must include:
    Four (4) years in each of the following:


    Serving as primary eTMF contact for pivotal studies, ensuring questions related to eTMF items are addressed in a timely manner.

    Applying knowledge of regulations such as ICH-GCP, FDA, or EMA when reviewing documentation to identify if a Quality Issue needs to be created in the eTMF system for further

    follow-up.


    Applying knowledge of regulations such as ICH-GCP, FDA, or EMA when providing guidance or answering questions to study team to ensure adherence to document standards.

    Three (3) years in each of the following:

    Serving as Subject Matter Expert (SME) for assigned studies, responsible for creating tools such as monthly dashboards to be presented to stakeholders during team meetings, including

    performing analysis of key metrics and key performance indicators (KPIs) for completeness, quality, and timeliness.

    Leading eTMF kick-off meeting for new studies, ensuring roles are assigned as per eTMF SOP.

    Assisting in the review and update of existing eTMF user roles bi-annually.

    Driving the creation of eTMF Plans, and Study-specific Master Lists.


    Post protocol approval obtaining all the required forms, documents, and authorizations prior to the creation of the study in the eTMF system.

    Applying knowledge of the DIA TMF reference model to assist Functional Leads to revise and update study specific Master List templates and Naming Conventions


    Collaborating with Associate Director on annual system Naming Convention updates to ensure documents are correctly uploaded into the eTMF system.

    Acting as inspection TMF SME for the assigned studies and preparing for Inspection Readiness activities including the following: conducting TMF gap analysis activities; updating BIMO

    checklists; and supporting mock inspections.


    Liaising with study's PM during Inspection readiness activities to identify missing documents and identify remediation strategy to obtain missing documents.

    Providing TMF related updates to team members.


    Acting as a part of core inspection team and as a backup for other studies to own key responsibilities including document requests, access to the TMF for the auditors and inspectors, ensuring easy retrieval of documents on request or helping other SMEs as per the inspection plan.

    Multiple positions


    Apply online:
    .

    #LI-DNI

    #J-18808-Ljbffr
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