Lead Research Associate - Clinical Data Manager (REDCap)

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.
• 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.

Requirements

• 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, Sick Leave, Holiday Leave, 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.

Pay Range

The anticipated salary range for this role is $82k-$109k and will be commensurate with experience.