Remote Clinical Data Manager — REDCap/CTDB Specialist

Saratoga Medical Center; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Saratoga Medical Center in the United States seeks a Remote Clinical Data Manager specialized in REDCap and CTDB to support NIH- or FDA-regulated trials. The role requires a Bachelor’s degree in life sciences, informatics or related field and 5+ years of clinical data management experience.

Responsibilities include designing CRFs, configuring and validating databases, data cleaning, and producing data extracts for analysis and DSMB review.

Qualifications

• Design and development of case report forms and data collection instruments
• Database configuration, validation, and testing with edit checks and access controls
• Data cleaning, discrepancy and query management, and reconciliation of safety 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
• Working knowledge of GCP (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

Responsibilities

• Develop and manage REDCap/CTDB study databases
• Ensure data integrity with validation, edit checks, and access controls
• Generate data extracts and documentation for analysis, DSMB reviews
• Create data management plans, data dictionaries, and database lock procedures

Job description

Saratoga Medical Center in the United States seeks a Remote Clinical Data Manager specialized in REDCap and CTDB to support NIH- or FDA-regulated trials. The role requires a Bachelor’s degree in life sciences, informatics or related field and 5+ years of clinical data management experience.

Responsibilities include designing CRFs, configuring and validating databases, data cleaning, and producing data extracts for analysis and DSMB review.