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.
• 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.
• Primary responsibility in training new staff (CDMs, SCDMs and new LCDMs) and accepting and executing 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 with B.A. or B.S. degree
• At least 5 years’ professional experience in clinical data management with Associate degree
• At least 8 years’ professional experience in clinical data management with High School Diploma
• Fluent Oral and written English language skills
• Proficient overall working knowledge of the clinical development process
• Demonstrated excellent project management and leadership skills

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