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
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.
Primary activities include responsibility for all protocol level start-up, in-life and database lock tasks and activities, and interaction with customers and stakeholders.
The role requires performing tasks with minimal guidance, supporting and executing any role or task in the team when needed, and primary responsibility in training new staff.
Matching 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.
Skills & Requirements
Must-have
end to end data management activities
data integrity review and reconciliation
query management
database lock preparation/execution
ICH-GCP guidelines
eCRFs, Time & Events Schedules, eCRF Entry Guidelines
Nice-to-have
comprehensive development of junior staff
effective interaction with business partners
opportunities to improve efficiency, effectiveness and quality
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
Proficient overall working knowledge of the clinical development process
Demonstrated excellent project management and leadership skills