Senior Manager, Clinical Data Management

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: July 17, 2021

Job Description:

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 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

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.

Keywords: Jazz Pharmaceuticals, Palo Alto , Senior Manager, Clinical Data Management, Other , Palo Alto, California