Data Standardization Specialist III

Leads the mapping of clinical trial protocol content to ICH M11 structured

protocol concepts, clinical data standards, controlled terminology, and structured

data elements.

–Responsible for standardizing protocol sections, data fields,

endpoint definitions, schedule of activities, investigational therapy information,

concomitant therapy data, demographics, procedures, and adverse event

reporting concepts.

–This role ensures that extracted protocol information is

consistent, reusable, machine-readable, and suitable for downstream FDA review

Do you have experience in ICH guidelines?

$140,000 a year - Full-time

BITS is a growing software development company in Washington DC area. We provide project management, database solutions, application development, infrastructure supports, network engineering, and high-end computing using innovative technologies to the Federal agencies. We are looking for a Data Standardization Specialist III for one of our FEDERAL projects.