Lead Clinical Data Manager

Vetamc

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.
  • Responsible for all protocol level start-up, in-life and database lock tasks and activities, including designing, creating, validating, reviewing, approving and maintaining data management tool specifications.
  • Primary responsibility in 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 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
  • encourages 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
  • General understanding of CDISC/Study Data Tabulation Model (SDTM)

Work Rights

Not specified

Tailored Resume

Cover Letter