Lead Clinical Data Manager

Merck & Co., Inc.

Rahway, NJ, US
**
End-to-end data management
Data integrity review
Query management
** Merck & Co., Inc. is seeking a Lead Clinical Data Manager (LCDM) in Rahway, NJ, responsible for overseeing clinical trial data management activities, ensuring compliance with SOPs and ICH-GCP guidelines. The ideal candidate should possess a strong background in clinical data management, effective communication skills, and the ability to lead and train junior staff while ensuring data integrity and quality. **

Job Summary

  • The Lead Clinical Data Manager is responsible for executing end-to-end data management activities pertaining to clinical trials, including data management tool development, validation and maintenance, data integrity review and reconciliation, and query management.
  • The role involves ensuring the quality and timely execution of deliverables at the trial level and may include leading the quality and maintenance of new/updated eDT/eCRF and associated Data Validation components.
  • This position requires interaction with customers and stakeholders, participation in user acceptance testing, and providing input into investigator meeting materials.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking a Lead Clinical Data Manager (LCDM) in Rahway, NJ, responsible for overseeing clinical trial data management activities, ensuring compliance with SOPs and ICH-GCP guidelines. The ideal candidate should possess a strong background in clinical data management, effective communication skills, and the ability to lead and train junior staff while ensuring data integrity and quality. **

Skills & Requirements

Must-have

  • end-to-end data management
  • data integrity review
  • query management
  • database lock preparation
  • ICH-GCP guidelines
  • eCRF design and validation
  • Data Validation components

Nice-to-have

  • junior staff development
  • effective interaction with business partners
  • process maintenance
  • cross-functional technical improvement projects

Key Requirements

  • At least 3 years' professional experience in clinical data management with a B.A. or B.S. degree
  • 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
  • Proficient overall working knowledge of the clinical development process
  • Ability to work independently with minimal guidance

Work Rights

Not specified

Tailored Resume

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