Lead Research Associate - Clinical Data Manager (REDCap)

Westat•Bethesda, MD

22d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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).
Develop requirements for EDC system and databases employing complex validation rules, and edit checks.
Assist with systems testing, configuration and usage questions.
Work with system developers to support development and implementation.