Job Summary

• The Lead Clinical Data Manager (LCDM) 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.
• Responsible for all protocol level start-up, in-life and database lock tasks and activities, interacting and communicating with customers and stakeholders both internal and external to GDMS when needed.
• Primary responsibility in training new staff (CDMs, SCDMs and new LCDMs) and accepts and executes special responsibilities related to process maintenance, data quality assessment, staff training and mentoring.

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Skills & Requirements

Key Requirements

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

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