Clinical Data Coordinator

About Navitas Life Sciences:

Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries.

At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider.

Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry.

Navitas Life Sciences is proud to be an HIG Portfolio company.

Website: www.navitaslifesciences.com

Responsibilities and functions:

Independently and accurately, review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures.

Independently and accurately, perform Medical Coding with MEDRA and WHODRUG Global for completeness, accuracy and consistency in accordance with all applicable procedures.

Accurately and consistently, apply data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures.

Perform Quality Reviews and appropriately address all issues.

Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures.

Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.

Independently and accurately, generate data queries to resolve data discrepancies.

Appropriately address responses to data queries and accurately update the clinical data as necessary.

Identify and accurately resolve all workflow or clinical data discrepant issues. Independently and accurately, prepare database test documentation and test data entry screens.

Assist with the validation of edit check programs. Assist with the development, review and the update of relevant Data Management Study Specific Procedures.

Accurately perform Serious Adverse Event reconciliation in accordance with all applicable procedures.

Accurately perform external data reconciliation in accordance with all applicable procedures.

Generate, review for accuracy and distribute status reports as requested.