• Senior Electronic Trial Master File Specialist

    Job Locations US-IL-Bannockburn
    Posted Date 2 weeks ago(2 weeks ago)
    Job ID
    2018-2510
    # of Openings
    1
    Category
    Clinical Development
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc., a Novartis Company, is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    AveXis is seeking a Senior Electronic Trial Master File (eTMF) Specialist. The Senior eTMF Specialist will be responsible to maintain the AveXis electronic Trial Master File (eTMF). This includes development and maintenance of an Expected Documents List (EDL), uploading study documentation, quality checking uploaded documents, working with the AveXis staff to ensure the eTMF is complete and inspection ready. 

    Responsibilities

    • Work daily in SharePoint for Clinical Operations non-study related activities.
    • Major Responsibilities:
    • Clinical documentation management and tracking skills
    • Task prioritization and timeline adherence
    • Use electronic systems and tools (e.g. Veeva VAULT, SharePoint, ACE, ComplianceWire, etc.)
    • Maintain an audit- and archive-ready trial master file
    • Participate in the development and ongoing management of processes and procedures for AveXis use of Veeva Vault eTMF.
    • Assist in the transitioning eTMF from SharePoint to Veeva VAULT system, which will house all the documentation for all studies.
    • Create, Upload, Quality Check documents in the Veeva VAULT on a daily basis.
    • Critically review document content to ensure accuracy and completeness.
    • Ensure required site documentation (Investigator Site File Documents, Investigational Product accountability documents, final study documents, and documents for inclusion in a regulatory filing, etc.) remains current in the eTMF during the conduct of a study.
    • Manage the eTMF, ensuring documents maintained in the file are appropriate and the content of those documents is accurate, complete, and consistent with processes and requirements in the Veeva VAULT system.
    • Participate in the preparation activities required for regulatory and QA audits of the eTMF.
    • Track and maintain study EDL and reports on study progress.
    • Maintain and ensure the completeness of all levels (i.e., Study Level, Country Level and Site Level) electronic Trial Master File (TMF) in accordance with process requirements.
    • Serve as key central contact for matters related to uploading communications, correspondence and associated documentation and as a subject matter expert on matters related to Veeva eTMF.
    • Track information between the study team and vendors, as assigned.
    • Manage the translation and tracking of translations for appropriate study documents, as assigned.
    • Manages study related activities, as assigned, in tandem with the global project team.
    • Supports other projects as assigned.
    • Identifies and contributes to areas of best practice and process improvement.

    Qualifications

    • A Bachelor degree is required.
    • 5+ years of experience, or extended education in clinical research/drug development.
    • Experience with eTMF, preferably Veeva Vault.
    • Familiarity with eTMF processes and procedures.
    • Familiar with concepts of clinical research and able to work effectively in a team environment.
    • Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required.
    • Ability to deal with time demands, incomplete information or unexpected events.
    • Must possess excellent Word, Excel and interpersonal skills.
    • Must have the ability to build and maintain positive relationships with management, peers, and direct reports.

     

    The level of this position will be based on the final candidate’s qualifications.

     

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

     

    AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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