• Project Specialist, Clinical Operations

    Job Locations US-IL-Bannockburn
    Posted Date 1 week ago(4/9/2019 12:05 PM)
    Job ID
    2019-3260
    # of Openings
    1
    Category
    Clinical Operations
  • 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 (ZOLGENSMA®). 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 Project Specialist, Clinical Operations that will be responsible for providing operational and program level support for several clinical trials (early through late phase) under the leadership of the assigned Clinical Trial Operations Manager/Program Lead. This role includes supporting the study team in the planning, set-up, maintenance and closeout of trials as applicable. The Project Specialist will be accountable to ensure adherence to standard operating procedures, good clinical practice/ICH, FDA-EMA/global regulations, relying on experience and guidance to plan and accomplish goals.

    Responsibilities

    • Support study teams in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
    • Support study teams by setting up and maintaining appropriate study tracking forms including: enrollment log/trial allocations forms, site and vendor contact lists, drug shipping logs, set up and maintenance of team membership and contact lists. Note: this may require use of CTMS or may be manual.
    • Contribute to setup and maintenance of information entered in a Clinical Trial Management System.
    • Contribute to ongoing review of documentation for ALCOA standards and upload of documentation to eTMF. Work with study team to establish and maintain eTMF tracker for all studies. Provide ongoing support to study team to ensure timely follow up on outstanding eTMF documentation including ongoing reconciliation activities.
    • Provide support in meeting scheduling and distribution of meeting agendas/minutes when required.
    • Assist in onboarding new team members including granting new study team members access to appropriate systems (e.g. EDC, CTMS, LMS, vendor systems, etc.).
    • Serve as point of contact to clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
    • Assist study team with preparation and distribution of study tools needed at study start up and throughout trial as appropriate.
    • Ensure projects are in compliance with GCP-ICH guidelines, Company and/or CRO SOPs and any local applicable regulations; liaise with internal department managers and/or external CRO team members as necessary (i.e., data management, quality, clinical supplies, CRO project specialist).
    • Coaching/training of CRAs or other team members in various aspects of specific clinical trials that are relevant to project issues.
    • Participate in process improvement initiatives as requested.

    Qualifications

    • Bachelor’s Degree required.
    • 2+ years Clinical Research Support of trials or equivalent experience.
    • Experience supporting multiple clinical trials required.
    • Experience supporting global clinical trials highly preferred.
    • Pediatric, CNS or Oncology experience highly
    • Research or health care related academic or work experience preferable.
    • Experience with CTMS and data systems (e.g., Veeva Vault, Medidata RAVE).
    • Excellent organization skills.
    • Excellent analytical, verbal, and written presentation skills with a working knowledge of Microsoft Office applications including Word, Excel, Access, PowerPoint, and
    • Able to work at a fast pace and manage multiple complex projects.

     

    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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