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

    bluebird bio
    bluebird bio Somerville, United States

    4 weeks ago

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    Description

    ABOUT THE NEST

    The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:

    • Persist for Purpose
    • Be Compassionate
    • Stay humble and curious
    • Keep it real
    • Celebrate (sm)all wins
    Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

    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

    bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.

    bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
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