Job Summary

• The Lead Clinical Data Manager 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 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 has primary responsibility in training new staff.

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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
• 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
• Ability to work under pressure in a changing environment with flexibility
• Ability to work independently and accept and act with appropriate accountability with minimal guidance
• 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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