• Associate Director, Clinical Trial Monitoring

    Job Locations US-IL-Bannockburn | US-Remote
    Posted Date 1 week ago(6/18/2019 2:08 PM)
    Job ID
    2019-3445
    # of Openings
    1
    Category
    Clinical Operations
  • Overview

    Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

     

    AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    AveXis is seeking an Associate Director, Clinical Trial Monitoring, who will help lead the Clinical Trials Monitoring team and manage CRAs in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting. 

    Responsibilities

    • Accountable for the quality of CRA performance of direct reports.
    • Monitor and evaluate employees in the current monitoring practices to ensure compliance.
    • Responsible for the coaching, development, and growth leading directly to improvement of talent of AveXis personnel within the assigned region to meet increasing levels of responsibility.
    • Ensures that standardized goals and objectives are implemented on a functional level in support of corporate and department goals for AveXis employees.
    • Accountable for all activities of site related study execution of assigned studies/ Monitors involving start­up, execution, and close­out.
    • Supports the development, implementation and execution of global strategies employed by Clinical Operations staff to meet corporate goals or directives.
    • Ensures proactive management of staff and collaborate on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the Director/Department Head in Clinical Operations.
    • Responsible for vendor oversight of services related to global monitoring activities.
    • Establish, analyze and review appropriate metrics to ensure staff are compliant with goals and objectives.
    • Support the identification of training needs within function and the development of training materials to meet those needs. May provide mentoring or training as required to improve core competency and skill set of the function or region.
    • Provide input amd implement continuous improvement processes for function or organization.
    • Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AveXis research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions.
    • Ensures compliance with the application and communication of all AveXis policies, procedures and fundamentals within the assigned region.
    • Ensures that all direct reports understand and work toward corporate, department, and individual goals and that the measures of those goals are understood and accepted.
    • Active membership on departmental management teams.
    • Ensuring harmonization of field and in-house monitoring practices.
    • Perform CRA mentoring, training, metrics analysis, and trip report review.
    • May participate in continuous improvement initiatives for function or department.

    Qualifications

    • A minimum of 1 year on-site monitoring experience.
    • A minimum of 7 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
    • Bachelor’s degree, preferably in a life science; Master’s degree preferred.
    • Approximately 50% overnight travel for meetings, oversight visits.
    • Analytical, negotiation, meeting management, cross-functional team and leadership skills as demonstrated at a management level.
    • Demonstrated computer skills (MS Office, MS PowerPoint, EDC, CTMS, IRWS and eTMF preferred).
    • Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
    • Knowledge of GCP as it relates to clinical trial management.
    • Strong written and verbal communication skills; learn quickly; handle multiple studies and aggressive timelines.

     

    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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