Clinical Data Manager – End-to-End Trial Data

Merck; Rahway (NJ); Hybrid; USD 72,000 - 113,000; Full time

Job summary

Merck is seeking a Clinical Data Manager (CDM) to execute end-to-end data management activities for clinical trials, including data collection, validation, query management, medical coding, and database lock preparation, per SOPs and ICH-GCP guidelines.

You will support data management tool development, conduct data quality reviews, coordinate with sites and vendors, assist with archival activities, and ensure adherence to KPIs and regulatory requirements.

Qualifications

• High School Diploma (or equivalent).
• Preferred: B.A. or B.S. degree, in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.

Responsibilities

• Participates in development and change request implementation of data management tools and systems under the direction of the SCDM/LCDM.
• Runs data integrity check reports in accordance with data review plans and SOPs.
• Raises questions to investigational site staff and internal/external vendors, reviews responses and data corrections to confirm issue resolution.
• Executes user acceptance testing of data management tools under guidance of SCDM/LCDM.
• Escalates overdue items and missing visits.
• Assists the Senior/Lead CDM with data management activities to resolve data issues prior to study database lock.
• Completes trial level archiving activities under the direction of SCDM/LCDM.
• Maintains compliance with key performance indicators and process expectations at the protocol level.
• Monitors data quality and cycle-time performance measures; performs root cause analysis and implements action plans.
• Communicates project status, risk assessment, and outstanding item resolution status to Senior/Lead CDM.

Skills

Adaptability

Analytical Problem Solving

Clinical Data Cleaning

Clinical Data Management

Data Collection Methods

Data Documentation

Data Integrity

Data Processing

Data Reporting

Data Review

Data Validation

Document Management

Good Clinical Practice (GCP)

Project Management

Teamwork

Education

High School Diploma (or equivalent)

B.A. or B.S. preferred in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline

Job description

Merck is seeking a Clinical Data Manager (CDM) to execute end-to-end data management activities for clinical trials, including data collection, validation, query management, medical coding, and database lock preparation, per SOPs and ICH-GCP guidelines.

You will support data management tool development, conduct data quality reviews, coordinate with sites and vendors, assist with archival activities, and ensure adherence to KPIs and regulatory requirements.