Clinical Data Manager – REDCap, CTDB

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and develop case report forms along with data collection instruments.

• Set up, validate, and test study databases, which includes edit checks and user access controls.

• Cleanse data, handle discrepancies and queries, and reconcile safety and external data.

• Generate data extracts, listings, and documentation for analysis, monitoring, and DSMB review.

• Draft data management plans, data dictionaries, and procedures for database lock.

• Provide support for NIH or FDA-regulated clinical research programs.

• Collaborate within a multidisciplinary team alongside Government clinical investigators, regulatory staff, and program officials.

⛳️ Requirements

• Bachelor's degree in life sciences, health informatics, computer science, or a related field.

• A Master's degree or CCDM certification is preferred.

• At least 5 years of experience in clinical data management.

• 3 or more years of experience in building and managing study databases in REDCap, CTDB, or similar systems.

• Proficient in designing and developing case report forms and data collection instruments.

• Skilled in database configuration, validation, and testing, including edit checks and user access controls.

• Experienced in data cleaning, discrepancy and query management, and reconciliation of safety and external data.

• Proven experience in producing data extracts, listings, and documentation for analysis, monitoring, and DSMB review.

• Knowledgeable in preparing data management plans, data dictionaries, and procedures for database lock.

• Familiar with CDISC standards and 21 CFR Part 11 requirements.

• More than 5 years of direct experience supporting NIH or FDA-regulated clinical research programs.

• Understand Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312, and 812 (as applicable), 45 CFR Part 46, and HIPAA.

• Current training in human subjects protections and GCP (e.g., CITI or equivalent).

• Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff, and program officials.

🏝️ Benefits

• Competitive rate and benefit options.

• Equal opportunity employment.