Lead Research Associate - Clinical Data Manager (REDCap)

Job title: Lead Research Associate - Clinical Data Manager (REDCap)

Westat is a leader in research, data collection and analysis, technical assistance, evaluation, and communications. Our evidence-based findings help clients in government and the private sector accelerate advancements in health, education, transportation, and social and economic policy. Our dedication to improving lives through research and our approach to projects grounded in investigative curiosity, statistical and data rigor, adaptive methods, and advanced technology are why clients find exceptional value in our work.

We are looking for a motivated and technically strong Clinical Data Manager to develop, configure, and support validation of specifications for clinical research protocols. A strong understanding of electronic Case Report Forms (eCRFs), surveys, and clinical databases (EDC, ePRO, eConsent) for clinical trial and clinical intervention study protocols and the ability to work with scientific protocol lead staff and systems developers is required. This role involves translating clinical study requirements into technical specifications and supporting system validation, ongoing data validation, and reporting for clinical studies. The Clinical Data Manager will work with a team of staff for each study protocol. This is a hybrid role, requiring 3 days per week on-site in Westat's Bethesda, Maryland office.

Westat is seeking a motivated and technically strong Clinical Data Manager to develop, configure, and support validation of specifications for clinical research protocols. This role emphasizes eCRF design, data validation, and collaboration with developers to ensure robust data capture and reporting for clinical studies. The position is hybrid with on-site work three days per week at the Bethesda, MD office.

What You'll Do

• Create and maintain study data management documents according to instructions (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User’s Guide, EDC Training and Certification Documents)
• Design and/or develop electronic Case Report Forms (eCRFs)
• Develop requirements for EDC systems and databases employing complex validation rules, and edit checks
• Assist with systems testing, configuration and usage questions
• Collaborate with system developers to support development and implementation

What We're Looking For

• MA/MS in science or related field (medical or computer science preferred) or other advanced degree with 2-4 years of relevant experience; or BA/BS in science or related field (medical or computer science preferred) with 8+ years of relevant experience
• Experience with clinical research, specifically data collection, management, and standards
• Experience with REDCap, Medidata Rave or similar EDC systems
• Knowledge of CDISC standards, FDA regulations, ICH guidelines, and GCPs – and their application to clinical trials
• Proficiency with MS Office and Box
• Strong communication and interpersonal skills; ability to work effectively in a team and independently

Nice to Have

• Technical proficiency in MS Office products and Box (already listed above)
• Autonomy and ability to work without close supervision

Compensation & Benefits

• Salary: $82,000–$109,000 per year (USD)
• Benefits include Employee Stock Ownership Plan, 401(k) Retirement Plan, Paid Parental Leave, Vacation (15 days/year), Sick Leave (9 days/year), Holiday Leave (7 government holidays + 2 floating holidays), Professional Development support, Health, Dental, Vision and other insurances, Short/Long Term Disability, Life and AD&D, Supplemental Life, Flexible Spending Account, and Health Savings Account.
• Additional information: Background screening may be required; U.S.-based employment; no visa sponsorship for this role.