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Clinical Trials Manager

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 www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

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 and liaise cross-functionally and externally on study deliverables, including but not limited to study budgets, timelines, clinical trial working group, study guidance and training, etc.
  • Prepare and maintain all study documentation and plans including but not limited to: Monitoring Plan, Study Operations Manual, Source Data Verification Plan, Deviation Plans, Risk Management Plans, Laboratory Manual, Safety Review Charters, Informed Consent Forms, CRFs, patient diaries, QOLs, etc.
  • Liaise with applicable functions for system related builds, designs and user testing, including but not limited to EDC, IRT, etc.
  • Provide Clinical Operations input into protocol development and study report completion
  • Manage clinical site monitoring activities (includes as needed on-site clinical monitoring responsibilities) to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
  • Track study metrics, patient enrollment, qualify, initiate, monitor, perform closeout activities, review site visit reports; and assist in coordination of data management activities
  • Coordinate, manage, and liaise with applicable functions for all clinical study supplies
  • Support contract negotiations with vendors and clinical sites for clinical trial services
  • Liaise with Data Management on data capture, cleaning, review, query resolution, data review and data base locking
  • Coordinate study team training, including Investigator’s Meetings, vendor and site training, etc.
  • Assure regulatory compliance of investigational sites with Sponsor’s SOPs and FDA and ICH guidelines
  • Ensures trial master file is current and maintained
  • Manage financial oversight for assigned studies

Minimum Requirements

  • BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
  • At least 5 years relevant clinical trials experience, in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)
  • Travel required.
  • Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations Demonstrates 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 Oncology is required

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.

Posted
09/14/2021
Location
Middle West, PA, US