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Senior Clinical Trial Manager - Hematology/Oncology Dublin Ireland,
Posted on : 03 June 2017
The Senior Clinical Trials Manager (Sr. CTM) will be a member of the Jazz Pharmaceuticals Development Operations team. The Clinical Trials Manager responsibilities include (but are not limited to) the following: Manage external vendors and contract research organizationsPrepare study documents such as the Monitoring Manual, Study Operations Manual, 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 materialsPlan 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 maintained Required Knowledge, Skills, and Abilities At least 5 years of experience in clinical trial managementExperience in Oncology is preferredProven Management of people in a matrixed environmentManagement of global clinical trialsDemonstrated working knowledge of GCP, ICH guidelines and FDA regulationsDemonstrated ability to work independently and in a team environmentTravel required. Must be willing to travel 15-25%, including international travelProficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)Excellent oral and written communication skills and strong organizational abilities Required/Preferred Education and LicensesBA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred Description 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, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.
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