Data Management Group Lead

Company Description

PSI is a leading Contract Research Organization with more than 27 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

The Data Management Group Lead is responsible for line management of a group of Data Management staff and provides input into department management The Group Lead is responsible for oversight of Data Management activities on their assigned projects

Department Management

• Line management of assigned Data Management staff
• Participates in hiring and dismissal of Data Management staff in consultation with Head Data Management

Resource Management and Training

• Provides input into resource allocation and utilization within Data Management
• Conducts assigned staff performance appraisal
• Develops and maintains Training Plans for assigned Data Management staff
• Conducts initial and ongoing training of Data Management staff
• Provides initial and ongoing training of PSI Operations staff in Data Management topics

Project Supervision

• Acts as an escalation point for project teams and company departments regarding clinical data management
• Acts as an escalation point for clients for all data management aspects of clinical projects and clinical data management reporting
• Oversees all Data Management activities within a clinical project
• Reviews and approves project-specific documents
• Attends client meetings as required
• Interacts with other company departments 
• Monitors contract scope, budget, and deliverables

Business Development

• Participates in the development of proposals for new studies
• Prepares and attends Bid Defense Meetings
• Manages Vendor relationship (vendor selection, vendor meetings, and the like

Quality Control & Quality Assurance

• Participates in the development of quality systems documents and templates pertaining to Data Management
• Prepares for and attends internal and third-party study and systems audits
• Follows up on and responds to audit findings requiring corrective actions

This position requires travel on an as needed basis to support client meetings, department meetings, and other relevant business.  

Qualifications

• College or University degree or an equivalent combination of education, training and experience that represents the required knowledge, skills and abilities
• Minimum of eight years of Data Management experience in clinical research
• At least two years in a Senior Data Manager role  

Additional Information

All your information will be kept confidential according to EEO guidelines.