Senior Manager, Clinical Data Management at JAZZ PHARMACEUTICALS PLC in Palo Alto, CA

Overview:

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.

Responsibilities:

The Sr. Manager, Clinical Data Management (Sr. Manager, CDM) will oversee the data management of clinical trials in a large or complex development program. S/he may also lead critical studies in this area of responsibility. S/he will provide oversight to the daily operations of Jazz Pharmaceuticals’ clinical studies through vendors. S/he may lead a small team of junior and senior Clinical Data Managers and/or lead a technical development area (e.g. process, innovation, training, etc.). S/he will facilitate effective internal and external relationships. S/he will be expected to contribute to the development and growth of the CDM group within the Clinical Development Operations (CDO) structure. S/he will fulfill the following functions:

Essential Functions

• Oversee (and sometimes lead) the data management of Phase 1 through Phase 4 clinical trials in a large or complex development program
• Provide leadership, and mentoring to junior and senior Clinical Data Managers assigned to his/her line management
• Participate in and/or lead the development and implementation within a technical development area (e.g. process and standards, innovation, training, etc.)
• Represent Clinical Data Management on the Development Core Team and/or Clinical Trial Working Groups as appropriate
• Provide input to the development and implementation of methods to demonstrate oversight of CROs and other vendors, and manage and/or monitor the progress of outsourced data management activities
• Provide input and direction in CRO and vendor selection and management
• Provide technical expertise for the development of data management and other clinical trial documents (Clinical 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 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 clinical data management resources within the area of responsibility
• Participate in the generation and approval of budgets and timelines

Required Knowledge, Skills, and Abilities

• Thorough knowledge of data management and its role in the drug development process
• Understanding of the contributions of other functions critical to the execution of clinical trials, and their interactions with data management
• Experience of all stages of a clinical trial and vendor oversight
• Experience of managing and mentoring clinical data managers
• Demonstrated knowledge of ICH/GCP guidelines as they relate to data management
• Thorough understanding of CDISC CDASH and SDTM standards
• Extensive experience managing CROs and other data vendors.
• Experience working with a globally distributed team
• Ability to work on and solve complex problems.
• Ability to prioritize and handle multiple tasks simultaneously.
• Effective leadership skills and proven ability to foster team productivity and cohesiveness.
• Excellent communication/interaction skills and experience in a dynamic and growing organization.
• Travel Required

Required/Preferred Education and Licenses

• Bachelor’s Degree required (Master’s Degree preferred) in the scientific/healthcare field
• At least eight years of experience in Clinical Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience