Job Opportunities

The Principal Data Manager serves as the HCRI contact with study sponsors on data management issues/activities and coordinates the receipt and processing of information for projects (e.g., coding dictionaries, format libraries, and transfer database specifications) as well as electronic data received from specialty groups utilized on projects. Other duties include project status reporting to HCRI project team and sponsors; coordinating the building, testing, validation, and maintenance of clinical databases; auto/manual coding of AEs, secondary diagnoses, and concomitant medications, as appropriate; data cleaning and correction to ensuring databases are well-validated and ready for transfer and/or statistical analyses; and maintaining DM Standard Operating Procedures (SOPs) for assigned projects. S/he may also coordinate activities of Associate Data Managers as appropriate.

Additionally, Principal Data Managers have line management responsibility for up to six Data Managers. In this capacity they participate in the hiring, training, retention, development, and review of junior staff members. They are also involved in department wide process development and reengineering and work with various committees to evaluate new technology and/or improve existing systems.

Requirements
• A Bachelor's degree or equivalent
• The candidate must have a minimum of five years experience working in clinical data management with 2 years of supervisory experience.
• Experience with device development a plus.
• Excellent written and oral communication skills, understanding of ICH/FDA guidance for Good Clinical Practice (GCP), and experience with Clintrial or another industry standard CDMS is required. • Previous supervisory experience or demonstrated team leadership preferred.
• Must be able to interact positively with a variety of individuals, sponsors, etc. and to handle sensitive issues in a professional, confidential manner.