• Job Description

  Req#: 10990
  Advantages of Joining Our Company:
  
  At our company, we strive to transform the lives of patients and their families by developing innovative medicines for serious diseases. Joining our team offers the following benefits:
  
  - Opportunity to work for a global biopharmaceutical company
  - Focus on developing life-changing medicines for patients with limited treatment options
  - Diverse portfolio of marketed medicines and novel product candidates
  - Exploration of new options for patients through cannabinoid science and innovative delivery technologies
  - Global reach, serving patients in nearly 75 countries
  
  Job Description:
  
  The Senior Clinical Trial Specialist (Sr CTS) supports moderately complex clinical trial activities in support of the Clinical Trial Manager. The Sr CTS works closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The Sr CTS may assist with vendor oversight and management. They will identify issues in a timely manner and escalate to management as appropriate. The Sr CTS will complete monitoring visit report review and perform co-monitoring or monitoring oversight visits. The core duties and responsibilities of the Sr CTS are as follows:
  
  Supports activities related to study/site feasibility, start-up, maintenance, and close-out.
  Manages study and site essential documents review, collection, tracking, etc. from study start-up through the maintenance and close-out period.
  Supports the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable.
  Ensures required study documents received, reviewed and filed in the Trial Master File (TMF) in accordance with GCP and applicable regulations.
  Organizes study-related meetings and maintains study logs, including risk/issue/decision logs.
  May lead and present at study-related meetings.
  May perform applicable site monitoring / co-monitoring visits.
  Addresses internal and site QA findings from audits.
  Manages, coordinates, and oversees activities from third-party vendors.
  Tracks and maintains general study information, including study status, enrollment, queries, deviations, and study level documents and plans.
  Oversees study sites, including site performance, metrics, and monitoring report review.
  Assists and supports study data related activities, including data review, query creation and resolution, and safety reviews.
  Participates in department and clinical trial team meetings and collaborative efforts.
  Provides oversight of CRO and vendor activities, including vendor management as assigned.
  Reviews and verifies contracted vendor activities, including vendor invoice review.
  Supports study reporting and tracking with applicable systems and technology.
  Supports study lead in aligning study timelines across functions.
  
  Required Knowledge, Skills, and Abilities:
  
  - 5 or more years of industry experience in Pharmaceutical, Biotechnology, or Contract Research Organization (CRO)
  - Previous site management experience is preferred
  - Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures
  - Understanding of study phases and general knowledge of how they apply to clinical development
  - Ability to work independently and in a team environment
  - Advanced knowledge of Word, Excel, and PowerPoint
  - Working knowledge of electronic Systems including Trial Master File, CTMS, etc.
  - Knowledge of computer applications in database management
  - Strong verbal and written communication skills required
  - 15% - 20% travel may be required
  
  Required/Preferred Education and Licenses:
  
  - Bachelor’s degree preferred
  - Clinical experience is preferred
  
  Additional Information:
  
  This Job Description provides a summary of the duties and/or characteristics of work performed and is not inclusive of every detail of the job for every individual assigned to the position. This description will be reviewed periodically and revised as duties and responsibilities change with business demands. Other duties not listed above may be assigned as needed.
  
  Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. 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.
  
  FOR US-BASED CANDIDATES ONLY: Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices. The anticipated base pay range for this role is $100,000-$131,250. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation, as well as discretionary equity grants. The successful candidate will also be eligible to participate in various benefits offerings, including medical, dental and vision insurance, a 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings, please visit our website.

• About the company

  Jazz Pharmaceuticals plc is a biopharmaceutical company based in Ireland.

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