The Associate Director, Data Management will oversee the data management of clinical trials in a particular therapeutic area or 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 programs through vendors. S/he may lead a team of data management professionals and will be expected to provide vision, leadership, and mentoring to their assigned team. S/he will facilitate effective internal and external relationships. S/he will be expected to contribute extensively to the development and growth of the Data Management group within the Clinical Operations structure.
- Oversee (and sometimes lead) the data management of Phase 1 through 4 clinical trials in a particular therapeutic area or development program
- Develop and implement methods to demonstrate oversight of CROs and other vendors
- 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, 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 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
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
- BA/BS, preferably in the scientific/healthcare field.
- At least ten years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
- Several years of study lead and supervisory experience
- For Hematology/Oncology, experience working with collaborative oncology groups
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.