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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.

Job Responsibilities

• Clinical Data Management: Creates and maintains 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). Designs and/or develops electronic Case Report Forms (eCRFs).
• Systems Specifications Development: Develop requirements for EDC system and databases employing complex validation rules, and edit checks.
• Technical Support: Assist with systems testing, configuration and usage questions.
• Collaboration: Work with system developers to support development and implementation.

Basic Qualifications

• MA/MS in science or related field (medical or computer science preferred) or other advanced degree with 2-4 years of relevant experience.; or a BA/BS in science or related field (medical or computer science preferred) with 8 or more years of relevant experience.
• Experience with clinical research, specifically data collection, management, and standards.
• Experience with REDCap, Medidata Rave or similar EDC systems.for reporting.
• Knowledge of CDISC standards, FDA regulations, ICH guidelines, and GCPs – and their application to clinical trials.

Preferred Qualifications

• Technical Proficiency: Knowledge of MS office products and Box.
• Communication: Able to communicate clearly and effectively both written and verbal. Strong interpersonal skills and ability to work effectively and collaboratively within a team environment.
• Autonomy: Proven ability to work independently.

Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance. Subject to plan requirements, employees may participate in:

• Employee Stock Ownership Plan
• 401(k) Retirement Plan
• Paid Parental Leave
• Vacation Leave (15 days per year)
• Sick Leave (9 days per year)
• Holiday Leave (7 government holidays and 2 floating holidays)
• Professional Development
• Health Advocate
• Employee Assistance Program
• Travel Accident Insurance
• Medical Insurance
• Dental Insurance
• Vision Insurance
• Short Term Disability Insurance
• Long Term Disability Insurance
• Life and AD&D Insurance
• Critical Illness Insurance
• Supplemental Life Insurance
• Flexible Spending Account
• Health Savings Account

Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the specific position, which may include, for example, identity verification, employment history, motor vehicle driving record history, and criminal or sexual offender records history. Any background screening results will be evaluated through an individualized assessment based on the individual’s specific record and the duties and requirements of the position.

This opportunity will be posted for a minimum of 5 days and applications will be accepted on an ongoing basis.

Employment Eligibility: This is a U.S.-based position. Candidates must be authorized to work in the United States on a full-time basis. Westat does not offer employment-based visa sponsorship (including H-1B sponsorship) for this role. Depending on project requirements, some positions may require employees to meet specific residency criteria.

Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, or any other protected status under applicable law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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