Clinical Data Manager — REDCap/CTDB

Saratoga Ascend; Oregon; Hybrid; USD 90,000 - 140,000; Full time

Job summary

Saratoga Medical is seeking a Remote Clinical Data Manager to oversee REDCap/CTDB studies. The role focuses on designing CRFs, configuring databases, and ensuring data integrity in NIH/FDA-regulated environments.

You will work with a multidisciplinary team of investigators and regulatory staff, manage data cleaning and query processes, generate data extracts, and contribute to study documentation and database lock procedures. Saratoga Medical Center is an equal opportunity employer.

Qualifications

• Bachelor's degree in life sciences, health informatics, computer science or a related field.
• Master's degree or CCDM certification preferred.
• 5+ years of clinical data management experience, including 3+ years with REDCap/CTDB.

Responsibilities

• Design and develop case report forms and data collection instruments.
• Database configuration, validation and testing with edit checks and user access controls.
• Data cleaning, discrepancy and query management, and reconciliation of safety data.
• Produce data extracts, listings and documentation for analysis and DSMB review.
• Prepare data management plans, data dictionaries and database lock procedures.
• Familiarity with CDISC standards and 21 CFR Part 11 requirements.
• Collaborate with government investigators, regulatory staff and program officials.

Skills

REDCap

CTDB

Data management

Data cleaning

CDISC standards

GCP regulatory

HIPAA

Documentation

Education

Bachelor's degree in life sciences / health informatics / computer science

Master's degree or CCDM certification preferred

Tools

REDCap

CTDB

Job description

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.