Lead Clinical Data Manager

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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, in compliance with 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 data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with SOPs and ICH-GCP guidelines.
  • 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 activities include interacting with customers and stakeholders, designing and maintaining data management tool specifications, coordinating user acceptance testing, and providing inputs into investigator meeting materials.

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, in compliance with 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 compliance
  • eCRFs, Time & Events Schedules, Edit Checks
  • Data Validation (DV) components

Nice-to-have

  • Support comprehensive development of junior staff
  • Encourage effective interaction with business partners
  • Monitor workload and resource allocation
  • Develop and deliver programs and materials

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/SDTM

Work Rights

Not specified

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