Saratoga Medical is hiring a 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
Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.
Skills Required
- Bachelor's degree in life sciences, health informatics, computer science, or a related field
- Master's degree
- CCDM certification
- At least 5 years of clinical data management experience
- At least 3 years building and managing study databases in REDCap, CTDB, or comparable systems
- Experience designing case report forms and data collection instruments
- Experience with database configuration, validation, testing, edit checks, and user access controls
- Experience with data cleaning, discrepancy and query management, and safety and external data reconciliation
- Experience producing data extracts, listings, and documentation for analysis, monitoring, and DSMB review
- Experience preparing data management plans, data dictionaries, and database lock procedures
- Familiarity with CDISC standards and 21 CFR Part 11 requirements
- At least 5 years supporting NIH or FDA-regulated clinical research programs
- Working knowledge of ICH E6 Good Clinical Practice and applicable 21 CFR, 45 CFR Part 46, and HIPAA requirements
- Current human subjects protections and GCP training, such as CITI or equivalent
- Experience working with government clinical investigators, regulatory staff, and program officials in a multidisciplinary team
What We Do
Saratoga Ascend is a trusted healthcare, IT, and life sciences solutions and staffing partner supporting federal, state, and military agencies nationwide. With decades of experience in complex government environments, we deliver end-to-end solutions that strengthen workforce readiness, ensure regulatory compliance, deliver efficiency, and improve outcomes. We have expanded beyond our traditional staffing roots by providing comprehensive solutions and services in clinical and behavioural health, program design and management, credentialing and onboarding, call and contact center support, program management, data analytics, and technology-enabled services. Our expertise in transition and implementation allows agencies to reduce risk, maintain continuity, and achieve operational excellence from day one. At Saratoga Ascend, we are committed to helping our partners navigate complexity, scale effectively, and deliver mission-critical services with confidence, accountability, and measurable results. Our Certifications: SBA Certified Women - Owned Small Business Joint Commission Certified NMSDC Certified
