Clinical Data Manager – REDCap, CTDB

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 13%

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Saratoga Ascend

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1985

🏥 Healthcare

🎯 Recruiter

🏛️ Government

Healthcare • Recruitment • Government

Saratoga Ascend is a federal- and state-focused healthcare workforce and solutions firm that connects cleared, credentialed healthcare professionals with government, military, and civilian healthcare facilities across the U. S. The company provides clinical and non-clinical staffing, clinical lab and scientific staffing, call center services, federal healthcare consulting, IT solutions, program and administrative support, and SLED (state, local, education) services. With a stated four-decade legacy, nationwide coverage, rapid-fill capabilities, strict credentialing/compliance processes, and operation under federal contract vehicles, Saratoga Ascend positions itself as a government-focused healthcare staffing and program management partner.

📋 Description

• 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

• 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

• Competitive rate and benefit options • Equal opportunity employment

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