Director, Data Management

Location
Bethesda, Maryland
Posted
Feb 28, 2018
Ref
2017106
Required Education
Masters Degree/MBA
Position Type
Full time

Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health and Information Technology to both private industry and government agency clients.  TRI is currently seeking a Director, Data Management to join our Bethesda, MD team.

Responsibilities

  • Oversee data collection for Phase I-IV clinical studies
  • Database Programming, and Data Management staff, with all incumbent supervisory responsibilities
  • Establish staff competency requirements and training programs
  • Mentor staff and aid in their development and achievement of competency standards
  • Standardize, improve, and develop SOPs for database development and data management.
  • Approve case report form design, data management plans, and edit specifications
  • Support project teams on achieving client satisfaction through delivery of quality data, on-time and on-budget
  • Ensure revenue and operating margin performance of the data management group to agreed targets
  • Review literature and research technologies/procedures for improving data management practices
  • Support business development and marketing activities at client presentations and professional seminars
  • Participate in proposal development and defense processes
  • Establish and maintain strategic client relationships

Requirements

  • MS in a related discipline with 15+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies, history of successful management, and expertise in one or more therapeutic areas.
  • 10 years’ experience as a project manager
  • Understanding of statistical concepts and techniques.
  • SAS programming knowledge
  • Expertise in EDC systems
  • Expert knowledge of clinical data standards and data flows as well as industry standards for submission of data
  • Client management experience
  • Excellent oral and written English and good presentation skills
  • Knowledge of the drug development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical and medical device business
  • Proven ability to plan and manage capital and operating budgets, as well as plan and advocate staffing resources  

Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.