Lead Clinical Data Manager

med-in.at

Not specified
End to end data management activities
Data integrity review and reconciliation
Query management
The Lead Clinical Data Manager (LCDM) position at med-in.at involves overseeing end-to-end data management activities for clinical trials, ensuring compliance with SOPs and ICH-GCP guidelines. The role requires strong leadership in data management tool development, staff training, and effective communication with stakeholders

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.
  • Primary responsibility in training new staff (CDMs, SCDMs and new LCDMs) and continually monitor for opportunities to improve efficiency, effectiveness and quality and implement changes as appropriate at the trial level, program level, TA level and department level.

Matching Summary

Match Score: 85

The Lead Clinical Data Manager (LCDM) position at med-in.at involves overseeing end-to-end data management activities for clinical trials, ensuring compliance with SOPs and ICH-GCP guidelines. The role requires strong leadership in data management tool development, staff training, and effective communication with stakeholders.

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

  • comprehensive development of junior staff
  • encourages effective interaction with business partners
  • monitors workload and resource allocation
  • quality and maintenance of any new/updated eDT/eCRF

Key Requirements

  • At least 3 years’ professional experience in clinical data management
  • Associate degree with at least 5 years’ professional experience
  • High School Diploma with at least 8 years’ professional experience
  • 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

Work Rights

Not specified

Tailored Resume

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