Job Summary

• The Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
• Primary activities include designing, creating, validating, reviewing, approving and maintaining data management tool specifications, coordinating user acceptance testing, and providing inputs into investigator meeting materials.
• The role requires performing tasks with minimal guidance, supporting and executing any role or task in the team when needed, and having primary responsibility in training new staff.

Matching Summary

Skills & Requirements

Key Requirements

• At least 3 years’ professional experience in clinical data management with a B.A. or B.S. degree
• At least 5 years’ professional experience in clinical data management with an Associate degree
• At least 8 years’ professional experience in clinical data management with a High School Diploma
• Proficient in Microsoft Office, especially MS Excel
• General understanding of CDISC/Study Data Tabulation Model (SDTM)

Work Rights