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.
• 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).

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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
• Good working knowledge of clinical practice and medical terminology
• Ability to work cross functionally and as part of a team
• 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)

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