Oversees and manages all aspects of data management operations including staffing and resourcing, project management, operations management and client management. Applies a high level of technical expertise to effectively lead all data management.
- Oversee day-to-day data management operations
- Serve as subject matter expert during client and vendor meetings
- Actively support business development in capabilities presentations to prospective and current clients
- Effectively provides input for department and clinical study budgets
- Liaise with internal and external cross-functional teams, sponsors, vendors, etc.
- Serve as project manager on clinical studies, as needed
- Work closely with Director of Data Management, Clinical Data Managers and Clinical Data Analyst to mentor data management staff
- Ensure project work is planned, resource allocated and is successfully executed
- Provide direction to staff when issues arise that the staff cannot resolve on their own
- Ensure proper training and development of staff
- Conduct regular meetings and completes year-end performance reviews with all direct reports
- Monitor performance of team and initiate process and resource improvement in partnership with Director of Data Management
- Adhere to all aspects of the Statistics & Data Corporation’s quality system
- Comply with Statistics & Data Corporation’s data integrity & business ethics requirements
- Perform other related duties incidental to the work described herein
Articulate and professional
Extensive experience in Clinical research
Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
Strong project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills
Effective leadership, budget forecast and implementation skills
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Education or Equivalent Experience:
- Bachelor’s degree in applied or life science preferred and minimum of 5 years experience in clinical trials (with at least 4 years in data management) and/or 3 years management (or leading a team) or equivalent education and work experience.