Lead Clinical Data Manager

leHACK

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 but not limited to data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Standard Operating Procedures (SOPs) and ICH-GCP guidelines

Job Summary

  • The Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
  • 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).

Matching Summary

The Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

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) and In-life Reports, Encoding and Data Management Plans (DMPs)

Nice-to-have

  • comprehensive development of junior staff
  • effective interaction with business partners
  • quality and maintenance of new/updated eDT/eCRF
  • appropriate use of Core/Generic, TA and Industry Standards concepts
  • develop and deliver programs and materials

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 in Microsoft Office, especially MS Excel

Work Rights

Not specified

Tailored Resume

Cover Letter