Job Summary

• The Lead Clinical Data Manager is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to 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.
• The LCDM may be appointed to Lead quality and maintenance of any new/updated eDT/eCRF and its associated Data Validation (DV) components across all Standards Libraries by ensuring the appropriate use of Core/Generic, TA and Industry Standards concepts.
• Primary responsibility in training new staff (CDMs, SCDMs and new LCDMs).

Matching Summary

Skills & Requirements

Key Requirements

• At least 3 years’ professional experience in clinical data management with B.A. or B.S. degree
• Associate degree with at least 5 years’ professional experience in clinical data management
• High School Diploma with at least 8 years’ professional experience in clinical data management
• Fluent Oral and written English language skills
• Proficient overall working knowledge of the clinical development process
• Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager
• Demonstrated excellent project management and leadership skills
• Proficient in Microsoft Office, especially MS Excel
• General understanding of CDISC/Study Data Tabulation Model (SDTM)

Work Rights