Lead Clinical Data Manager

Mdcrecruiting

Data management tool and system development
Data integrity review and reconciliation
Query management and database lock preparation
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, and interact and communicate with customers and stakeholders both internal and external to GDMS when needed.
  • Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/or other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes, leading or participating in cross functional technical improvement projects, etc.

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

  • Data management tool and system development
  • Data integrity review and reconciliation
  • Query management and database lock preparation
  • Compliance with SOPs and ICH-GCP guidelines
  • Global operational issues into study design
  • Metrics control plan and quality assessment indicators

Nice-to-have

  • Support comprehensive development of junior staff
  • Encourage effective interaction with business partners
  • Opportunities to improve efficiency and effectiveness

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
  • Knowledge of applicable regulations and policies
  • Proficient overall working knowledge of the clinical development process
  • Good working knowledge of clinical practice and medical terminology
  • Demonstrated excellent project management and leadership skills

Work Rights

Not specified

Tailored Resume

Cover Letter