Job Id : INJS1016

Position : Clinical Data Manager

Job Type : W2

Location : Palo Alto CA

Email : hr@innovitusa.com

Description :

• Clinical Data Manager will oversee the data management of clinical trials in a small 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 small 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 to the development and growth of the Data Management group within the Clinical Operations structure
• You will Oversee (and sometimes lead) the data management of Phase 1 through 4 clinical trials in a small development program
• Represent Data Management on the Development Core Team and/or Clinical Trial Working Groups as appropriate
• Develop and implement methods to demonstrate oversight of 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 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 Qualification:  Bachelor’s degree or its equivalent in Biostatistics, Pharmacy and/or in a related field of study.