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Senior Clinical Trials Manager

Company: Jazz Pharmaceuticals
Location: Harrisburg
Posted on: September 20, 2022

Job Description:

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter. Essential FunctionsManage external vendors and contract research organizationsPrepare study documents such as the Monitoring Manual, Study OperationsManual, Source Data Verification Plan and Laboratory ManualCoordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documentsAssist with protocol development and study report completionManage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocolsProvide guidance, direction, and management to CRAsTrack patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activitiesCoordinate study suppliesNegotiate contracts with vendors of clinical trial servicesReview Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetingsAssist and support data query processAssure regulatory compliance of investigational sites with Jazz Pharmaceuticals SOPs and FDA and ICH guidelinesEnsures trial master file is current and maintainedRequired Knowledge, Skills, and AbilitiesAt least 5 years of experience in clinical trial management. Experience in Neurology is preferredProven Management of people in a matrixed environment Management of global clinical trialsDemonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environmentTravel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)Excellent oral and written communication skills and strong organizational abilitiesRequired/Preferred Education and LicensesBA/BS, nursing degree, or advanced degree. Degree in the life sciences preferredDescription of Physical DemandsOccasional mobility within office environment. Routinely sitting for extended periods of time.Constantly operating a computer, printer, telephone and other similar office machinery.Description of Work EnvironmentWork indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.Frequent computer use at workstation.May move from one work location to another occasionally.Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.Occasional public contact requiring appropriate business apparel. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Keywords: Jazz Pharmaceuticals, Harrisburg , Senior Clinical Trials Manager, Healthcare , Harrisburg, Pennsylvania

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