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
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.
Works with management to maintain the consistent execution of quality global procedures, monitors workload and resource allocation, and supports the comprehensive development of junior staff.
Accountable for the quality and timely execution and delivery of deliverables at the trial level, and may lead quality and maintenance of any new/updated eDT/eCRF and its associated Data Validation (DV) components.
Matching 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.
Skills & Requirements
Must-have
end to end data management
data integrity review
query management
database lock preparation
ICH-GCP guidelines
eCRF design and validation
Data Validation components
Nice-to-have
support junior staff
improve efficiency and quality
work under pressure
work independently
coordinate work of others
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
Proficient in Microsoft Office, especially MS Excel
General understanding of CDISC/Study Data Tabulation Model (SDTM)