Clinical Data Management Director

6 hours ago

Raleigh North Carolina, United States Statistics & Data Corporation (SDC) Full time
Job Summary

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 tasks.

Key Responsibilities
  • Oversees day-to-day data management operations, ensuring on-time and quality deliverables and excellent client service and satisfaction
  • Manages one or more key accounts and studies; interfaces with the client to address feedback, ensure risks and issues are resolved
  • Serves as subject matter expert during client and vendor meetings
  • Leads teams located globally to deliver all aspects in Data Management, including the Database build processes
  • Performs independent review or quality review of all team deliverables prior to sending to client
  • Performs all client communications across the DM functions; face-to-face, teleconferences, and emails for lead role tasks
  • Performs internal escalations, project status updates, and project management functions, including updates to PM systems
  • Actively supports business development in capabilities presentations to prospective and current clients
  • Effectively provides input for department and clinical study budgets
  • Liaises with internal and external cross-functional teams, sponsors, vendors, etc.
  • Serves as Project Manager on clinical studies, as needed
  • Works closely with Director of Data Management, Clinical Data Managers, and Clinical Data Analyst to mentor data management staff
  • Ensures project work is planned, resource allocated, and is successfully executed
  • Provides direction to staff when issues arise that the staff cannot resolve on their own
  • Ensures proper training and development of staff
  • Conducts regular meetings, actively manages performance, and completes year-end performance reviews with all direct reports
  • Monitors performance of team and initiates process and resource improvement in partnership with Director of Data Management
  • Adheres to all aspects of the company's quality system
  • Complies with the company's data integrity and business ethics requirements
  • Performs other related duties incidental to the work described herein
  • Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
RequirementsRequired Skills
  • Articulate and professional
  • Extensive experience in clinical research and Data Management in multiple therapeutic areas
  • Electronic Data Capturing (EDC) RAVE experience
  • 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
  • May Require Travel up to 20%
Education or Equivalent Experience
  • Master's degree (preferably in Engineering, Applied or Life Science) and at least three (3) years of experience in Clinical Data Management, including leading several clinical studies, or a Bachelor's degree (preferably in Engineering, Applied or Life Science) with a minimum of five (5) years in DM
  • One year of experience in direct management of personnel
  • Clinical research in a CRO setting is preferred

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