Clinical Data Manager — REDCap/CTDB

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Data Manager — REDCap/CTDB

Remote, US

Saratoga Medical is hiring a Remote, Clinical Data Manager – REDCap / CTDB . Package includes competitive rate and benefit options.

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.