Overview: Jazz Pharmaceuticals is an internationalbiopharmaceutical company focused on improving patients' lives byidentifying, developing and commercializing meaningful productsthat address unmet medical needs. We are continuing to expand ourcommercial product portfolio and our research and developmentpipeline in therapeutic areas that can leverage our uniqueexpertise. Our therapeutic areas of focus include sleep andhematology/oncology - areas in which we have a deep understandingof the patient journey and a suite of products and productcandidates to address critical needs. We are looking for the bestand brightest talent to join our team. If you're looking to be apart of a company with an unwavering commitment to improvingpatients' lives and being a great place to work, we hope you'llexplore our career openings and get to know Jazz Pharmaceuticals.Responsibilities: The Senior Clinical Trial Specialist (SR CTS)supports moderately complex clinical trial activities in support ofthe Clinical Trial Manager. The SR CTS works closely with theclinical trial team to ensure site related start-up throughclose-out activities are conducted according to Good ClinicalPractice (GCP) and relevant SOP's. The SR CTS may assist withvendor oversight and management. They will identify issues in atimely manner and escalates to management as appropriate. The SRCTS may complete monitoring visit report review and performco-monitoring. The core duties and responsibilities of the SR CTSare delineated below. Responsibilities Manages Site EssentialDocuments review during study start-up, maintenance and close-outperiod Prepares study documents and manuals (i.e. consent forms,site instructions, study specific material such as the Manual ofOperations, Pharmacy binder, etc.) Ensures tracking of essentialdocuments are received and filed in the TMF, reviews site documentsfor accuracy; provides clinical team support with TMF filing andmanagement Ensures tracking of patient status throughout thestudy at investigative sites Review and approve trip reports,track data query reports, site visit metrics, and overall siteperformance May perform site initiation, routine monitoring andclose-out visits at a limited # of clinical sites, as well ascomonitoring with local CRAs and CRO personnel. Reviews datagenerated from clinical sites and assists in resolving subjecteligibility and protocol deviation issues Assist in thepreparation of, and may present at investigator vendor meetings andworkshops Actively involved in organization of team and vendormeetings including preparation of agenda/ minute taking andupdating any risk/ issue/ decision logs Actively involved in theperformance of study feasibility assessments Adheres to studytimelines, quality, and budget for assigned studies Providesrapid action to address both internal and site QA findings fromaudits Coordinate the activities from third party vendorsincluding metrics, accruals, process planning, and implementation Tracking and maintaining study status updates internally andexternally Assist and support data query process Routinelyparticipates in department and clinical trial team meetings andparticipate in collaborative efforts (e.g. protocol development,CRO selection, departmental initiatives, etc.) Be able to workcross-functional with Provides oversite of CRO and vendoractivities Review and verification of contacted vendor activitiesincluding vendor invoice review Requirements Bachelor's degreepreferred 5 or more years industry experience fromPharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 years of site management experience Previous site monitoring experience is preferred Clinicalexperience with the therapeutic area of Oncology is preferred Working knowledge in Good Clinical Practices (GCP) regulations andStandard Operating Procedures Understanding of study phases andgeneral knowledge of how they apply to clinical development Demonstrated ability to work independently and in a teamenvironment Advanced knowledge of Word, Excel, and PowerPoint. Strong verbal and written communication skills required. 15% -20% travel may be required Description of Physical Demands Occasional mobility within office environment. Routinely sittingfor extended periods of time. Constantly operating a computer,printer, telephone and other similar office machinery. Descriptionof Work Environment Work indoors in normal office environmentwith little exposure to excessive noise, dust, fumes, vibrationsand temperature changes. Frequent computer use at workstation. May move from one work location to another occasionally. Responsibilities may require a work schedule that may includeworking outside of "normal" work hours, in order to meet businessdemands. Occasional public contact requiring appropriate businessapparel. Jazz Pharmaceuticals is an equal opportunity/affirmativeaction employer and all qualified applicants will receiveconsideration for employment without regard to race, color,religion, sex, national origin, disability status, protectedveteran status, or any characteristic protected bylaw.

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Senior Clinical Trial Specialist