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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.
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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
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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.
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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