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Clinical Data Manager – REDCap, CTDB
Saratoga Ascend. Design and develop case report forms and data collection instruments .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical data management, including database design, validation, and compliance with regulatory standards. Proficient in collaborating within multidisciplinary teams to support NIH or FDA-regulated clinical research programs.
Highest-signal resume keywords
Clinical Data Management ExperienceREDCap Database ManagementData Cleaning and ReconciliationCDISC Standards FamiliarityGood Clinical Practice Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Case Report Form DesignData Collection Instrument DevelopmentDatabase ConfigurationData Validation and TestingData Extracts ProductionData Management Plans PreparationData Dictionaries CreationDatabase Lock ProceduresDiscrepancy ManagementUser Access Controls
Soft Skills
CollaborationCommunicationProblem-SolvingAttention to DetailTeamwork
Tools & Technologies
REDCapCTDBData Management Software
Certifications & Qualifications
CCDM CertificationGCP Training (CITI or Equivalent)
Industry Keywords
NIH-Regulated ResearchFDA-Regulated ResearchGood Clinical Practice (ICH E6)21 CFR Part 11HIPAA ComplianceClinical ResearchMultidisciplinary Team Collaboration
About the role
Key responsibilities & impact- Design and develop case report forms and data collection instruments
- Configure, validate and test study databases, including edit checks and user access controls
- Clean data, manage discrepancies and queries, and reconcile safety and external data
- Produce data extracts, listings and documentation for analysis, monitoring and DSMB review
- Prepare data management plans, data dictionaries and database lock procedures
- Support NIH or FDA-regulated clinical research programs
- Work in a multidisciplinary team alongside Government clinical investigators, regulatory staff and program officials
Requirements
What you’ll need- Bachelor's degree in life sciences, health informatics, computer science or a related field
- Master's degree or CCDM certification preferred
- Minimum of 5 years of clinical data management experience
- 3 or more years building and managing study databases in REDCap, CTDB or comparable systems
- Experience with case report form and data collection instrument design and development
- Experience with database configuration, validation and testing, including edit checks and user access controls
- Experience with data cleaning, discrepancy and query management, and reconciliation of safety and external data
- 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
- 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
Benefits
Comp & perks- Competitive rate and benefit options
- Equal opportunity employment