Lead Clinical Data Manager

MOBS Lab

Rahway, NJ, USA
**
End to end data management activities
Data integrity review and reconciliation
Query management
** MOBS Lab is seeking a Lead Clinical Data Manager (LCDM) to oversee data management activities for clinical trials, ensuring compliance with SOPs and ICH-GCP guidelines. The role requires strong leadership and collaboration skills, along with a solid background in clinical data management. **

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 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 across all Standards Libraries.
  • Primary responsibility includes training new staff (CDMs, SCDMs and new LCDMs) and performing tasks with minimal guidance from manager(s).

Matching Summary

Match Score: 75

** MOBS Lab is seeking a Lead Clinical Data Manager (LCDM) to oversee data management activities for clinical trials, ensuring compliance with SOPs and ICH-GCP guidelines. The role requires strong leadership and collaboration skills, along with a solid background in clinical data management. **

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
  • effective interaction with business partners
  • quality and maintenance of new/updated eDT/eCRF
  • Core/Generic, TA and Industry Standards concepts
  • improve efficiency, effectiveness and quality

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
  • Ability to work cross functionally and as part of a team
  • Ability to work under pressure in a changing environment with flexibility
  • Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager
  • Ability to coordinate the work of others and influence decision making
  • Exceptional communication skills (oral and written)
  • Exceptional organizational, problem-solving and negotiating skills
  • Demonstrated excellent project management and leadership skills
  • Proficient in Microsoft Office, especially MS Excel
  • General understanding of CDISC/Study Data Tabulation Model (SDTM)

Work Rights

Not specified

Tailored Resume

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