Description
- Recruits, trains and manages employees and consultants with area of responsibility; support development training standards
- Contributes to technical infrastructure of the Data Management and process improvement
- Manages DM related timelines. Coordinates and synchronizes deliverables / milestones with the overall Study Execution Team timelines
- Responsible for building effective DM vendor relationships for all assigned studies. Involved in RFP development, contract negotiation and selection of DM and/or technology, as needed Escalate issues with proposed solutions, as necessary
- Implements documentation and archival standards of Data Management deliverables including DM systems, databases, programs, and specifications
- Implements methods of achievement of major reporting deliverables and milestones for regulatory submissions
- Working with IT, ensures that local IT infrastructure meets Biometrics needs and global standards
- Project management for programming deliverables for one or more projects as required
- Supports budget and resource planning across one or more projects
- Develops, applies and promotes consistent Data Management standards through standard processes and SOPs
- Manages group of internal data managers, consultant data managers. Mentors and develops direct employees
- Provide training of the CRF completion guidelines, EDC system at Investigators' meeting and to internal and external project members as needed
- Represents the function in external professional initiates and organization to identify industry best practices
Other Duties as assigned
Skills:
- Expert skills in a pharmaceutical or CRO working in a FDA regulated environment
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines; Strong well-rounded technical skill, SAS, SDTM and CDISC
- Requires demonstrated working knowledge of data management systems and scientific principles
- Requires solid knowledge of clinical trial process and regulatory requirements
- Understands and applies data management technology, software languages and computer systems
- Demonstrate knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
- Skilled in multiple computer-based tools, in addition to software programs such as Word, PowerPoint, Excel, etc.
To find out more about Real please visit www.realstaffing.com