Title: Director, Clinical Data Management

Company: i3 Statprobe (a UnitedHealth Group company)

Location: any i3 Statprobe office - Ann Arbor, MI, Austin, TX, Basking Ridge, NJ, Cary, NC, Eden Prairie, MN, Lexington, KY, San Diego, CA or Burlington, Ontario, Canada.

Salary: dependent upon experience

Job Description:

i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis and reporting for clinical trials across all phases of research.

The Director, Data Management is responsible for the overall administrative, management, and technical functions of the data management division.

Other responsibilities

• Represent division to project teams, management, and sponsors
• Create position descriptions, initiate personnel actions and approve travel/leave requests
• Hire, manage and train senior personnel
• Establish performance and quality standards for division
• Oversee the implementation and management of data management systems
• Evaluate and monitor resources and plan resource allocation for all projects
• Develop policies for access, administration and security of clinical trial databases
• Approve database locks and authorize release of data to Statisticians or sponsors.
• Stay abreast of information relevant to data management processes through literature reviews and attendance at meetings/conferences
• Interact with other i3 departments such as Biostatistics, IS, Medical Affairs and Project Management to ensure a high level of client satisfaction through successful execution of projects
• Facilitate process harmonization with other i3 Data Management sites
• Assist in directing global data management projects to ensure the seamless provision of services

Qualifications

• BS degree required; advanced degree preferred
• Extensive clinical data management and line management experience
• Ability to work in a fast-paced, team-oriented environment
• Strong knowledge of industry standard clinical data management systems and regulatory requirements
• Willingness to travel

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Reply to:

For immediate consideration, please email your resume to Pam Livingston - pamela.livingston@i3global.com. You can also view all of our open positions by going to www.i3careers.com.