Senior CDM Trial Lead — End-to-End Data Strategy

Merck & Co.; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co. seeks an experienced CDM Trial Lead to drive end-to-end data management for assigned studies. You will coordinate data collection, validation, and queries across diverse data sources, ensuring compliance with ICH-GCP and regulatory standards.

Lead cross-functional teams, mentor staff, and promote data integrity and inspection readiness. You will partner with site monitoring, medical monitoring, and governance bodies to optimize CDMS processes and deliver timely, quality data for

Qualifications

• Requires extensive experience in data management for clinical trials.
• Knowledge of CDISC standards (SDTM, CDASH, Define-XML) and data standards.
• Strong project leadership and regulatory/compliance understanding.

Responsibilities

• Lead end-to-end data management for studies from start-up to database lock.
• Oversee data collection design, data validation, and query strategy.
• Manage cross-functional data interfaces and vendor interactions.
• Ensure risk-based quality oversight and inspection readiness.
• Oversee UAT and change control across study lifecycle.

Skills

Clinical data management

Project leadership

Risk management

CDISC standards

Fluent English

Education

Bachelor's degree in Life sciences or related field

Advanced degree (MS/PhD)

Tools

EDC systems

eCOA

Define-XML

Job description

Merck & Co. seeks an experienced CDM Trial Lead to drive end-to-end data management for assigned studies. You will coordinate data collection, validation, and queries across diverse data sources, ensuring compliance with ICH-GCP and regulatory standards.

Lead cross-functional teams, mentor staff, and promote data integrity and inspection readiness. You will partner with site monitoring, medical monitoring, and governance bodies to optimize CDMS processes and deliver timely, quality data for