External Data Reviewer Full-time Job
Nov 30th, -0001 at 00:00 IT & Telecoms Hyderabad 11 views Reference: 3599Job Details
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Responsibilities/Duties: • Ensure electronic lab data contains all protocol specified lab parameters, is in correct format and data populates to the specified fields and patients correctly. • Review data discrepancies generated by study specific edit checks for laboratory data and assist in preparation of data clarification forms sent to the site or the central lab. Also, review missing/updated central laboratory data for potential request and substitution of local laboratory data. • Perform 100% validation review of the electronically transmitted data for 5% of total number of patients in the study for loading purposes. • Assist CDM Manager with review of laboratory edit checks, laboratory status reports and laboratory listings as necessary. Interact with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites.