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, and interact and communicate with customers and stakeholders both internal and external to GDMS when needed.
• Primary responsibility in training new staff (CDMs, SCDMs and new LCDMs) and performs tasks with minimal guidance from manager(s).

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Skills & Requirements

Key Requirements

• At least B.A. or B.S. degree with at least 3 years’ professional experience in clinical data management
• 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
• Knowledge of applicable regulations and policies
• Proficient overall working knowledge of the clinical development process
• Good working knowledge of clinical practice and medical terminology
• Ability to work cross functionally and as part of a team
• Be able to work under pressure in a changing environment with flexibility
• Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager
• Ability to coordinate the work of others and influence decision making
• Exceptional communication skills (oral and written)
• Exceptional organizational, problem-solving and negotiating skills
• Demonstrated excellent project management and leadership skills
• Proficient in Microsoft Office, especially MS Excel
• General understanding of CDISC/Study Data Tabulation Model (SDTM) and corresponding implementation guides, CDISC terminologies and the related regulations for submission deliverables

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