Jazz Pharmaceuticals

  • Clinical Trials Manager

    Job Post Information* : Posted Date 2 months ago(4/17/2018 3:29 AM)
    ID
    2018-3523
    # of Openings
    1
    Category
    Research & Development
    Advertised Location : Location
    UK-Oxford
    Job Post Information* : External Company Name
    Jazz Pharmaceuticals
    Job Post Information* : External Company URL
    https://www.jazzpharma.com/
    Advertised Location : Address
    Spires House
    Advertised Location : Postal Code
    OX4 2RW
  • Overview

    Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


    Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


    We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

    Position Profile

    Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by

    identifying, developing, and commercializing meaningful products that address unmet medical needs.

    The Clinical Trials Manager (CTM) will be a member of the Jazz Pharmaceuticals Development Operations team. The Clinical Trials Manager will manage individual clinical trials and/or programs.

    Essential Functions

    • Manage external vendors and contract research organizations
    • Track vendor/study budgets
    • Prepare/Review study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
    • Coordinate and collaborate with the clinical study team the design of study materials such as CRFs, patient diaries, study participation cards and source documents
    • Assist with protocol development and study report completion
    • Manage monitoring activities (may include routine on-site clinical monitoring and/or co-monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
    • Provide guidance, direction, and management to CRAs
    • Track patient enrolment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
    • Coordinate study supplies
    • Support  contract negotiation process with vendors of clinical trial services
    • Review Informed Consent Forms, CRFs, and study related materials
    • Plan and participate in investigator meetings
    • Assist and support data query process
    • Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
    • Ensures trial master file is current and maintained

    Required Knowledge, Skills, and Abilities

    • Proven track record of escalating and relevant clinical trials experience, with extensive experience as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)
    • Travel required.
    • Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
    • Demonstrated ability to work independently and in a team environment
    • Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
    • Excellent oral and written communication skills and strong organizational abilities
    • Experience in CNS and / or oncology is preferred

    Required/Preferred Education and Licenses

    • BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred

    Description of Physical Demands

    • Responsibilities will require working outside of “normal” hours, in order to meet business demands.

    Jazz Pharmaceuticals is an Equal Opportunity Employer.

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