Lead Clinical Data Manager

Imsapharma Com Ar

End to end data management activities
Data integrity review and reconciliation
Query management
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.
  • The LCDM is accountable for the quality and timely execution and delivery of deliverables at the trial level and may be appointed to lead quality and maintenance of any new/updated eDT/eCRF and its associated Data Validation (DV) components.
  • Primary responsibility includes training new staff (CDMs, SCDMs and new LCDMs) and performing tasks with minimal guidance from manager(s).

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 activities
  • data integrity review and reconciliation
  • query management
  • database lock preparation/execution
  • ICH-GCP guidelines
  • eCRFs, Time & Events Schedules, eCRF Entry Guidelines
  • Edit Checks, Data Review Plans (DRPs)
  • In-life Reports, Encoding and Data Management Plans (DMPs)

Nice-to-have

  • support comprehensive development of junior staff
  • encourage effective interaction with business partners
  • monitor workload and resource allocation
  • continually monitor for opportunities to improve efficiency

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
  • Demonstrated excellent project management and leadership skills

Work Rights

Not specified

Tailored Resume

Cover Letter