Jazz Pharmaceuticals

Principal Clinical Data Manager

Job Locations US-CA-Palo Alto
Posted Date 1 week ago(3/13/2018 1:34 PM)
Job ID
# of Openings
Research & Development


Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

Position Profile

Apply knowledge of clinical studies and research database management to oversee the analysis and management of clinical trials data in a small development program. Oversee (and may lead) the data management of Phase 1 through 4 clinical trials, including the design and validation of clinical databases and processing of clinical data. Represent Data Management on the Development Core Team and/or Clinical Trial Working Groups as appropriate. Develop and implement methods to demonstrate oversight of Contract Research Organizations (CROs) and other vendors, and manage and/or monitor the progress of outsourced data management activities. Provide direction and leadership in CRO and vendor selection and management. Provide technical expertise for the development of data management and other clinical trial documents (Data Management Plans and associated documents, Protocols, Centralized Monitoring Plans, Statistical Analysis Plans, etc.) and trial conduct.

Be responsible for and manage data management activity of Clinical Data Managers assigned to his/her trials. Ensure that the Data Management component of the Trial Master File (TMF) and other documentation required to support regulatory submissions and inspections are maintained to the standard required. Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence. Contribute to strategic planning to ensure optimized use of data management resources within the area of responsibility. Provide vision, leadership, and mentoring to staff assigned to his/her line management. Participate in and/or lead the development and implementation of standards and processes related to both clinical data and risk-based trial management. Participate in the generation and approval of budgets and timelines.

Education Required: Bachelor or foreign equivalent in Healthcare, Life Sciences, Microbiology, Statistics, Mathematics, or a related field.

Experience Required: 8 years progressive experience as Clinical Data Associate, Clinical Data Manager, Senior Clinical Data Manager or related occupation.

Special Requirements: Must have at least 8 years of prior work experience in each of the following:

  • Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
  • Performing core Data Management tasks for clinical studies

Must have at least 2 years of prior work experience in each of the following:

  • Project management skills
  • Defining the scope and focus of Phase 1-4 clinical studies
  • Comprehensive understanding of regulatory guidelines and industry standards including ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, and WHO Drug Dictionaries, and their application to Data Management practice

Occasional telecommuting permitted.

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.


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