Remote,
Clinical Data Manager - REDCap / CTDB Package includes competitive rate and benefit options. Please see qualifications below and submit your resume if you are interested in being considered:
Education: Bachelor's degree in life sciences, health informatics, computer science or a related field; master's degree or CCDM certification preferred.
Experience: Minimum of 5 years of clinical data management experience, including 3 or more years building and managing study databases in REDCap, CTDB or comparable systems.
Qualifications:- Design and development of case report forms and data collection instruments
- Database configuration, validation and testing, including edit checks and user access controls
- Data cleaning, discrepancy and query management, and reconciliation of safety and external data
- Production of data extracts, listings and documentation for analysis, monitoring and DSMB review
- Preparation of data management plans, data dictionaries and database lock procedures
- Familiarity with CDISC standards and 21 CFR Part 11 requirements
- Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs
- Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA
- Current human subjects protections and GCP training (e.g., CITI or equivalent)
- Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials
