Senior CDM Trial Lead: Data Strategy & Delivery

Merck & Co.; Rahway (NJ); On-site; USD 140,000 - 200,000; Full time

Job summary

Merck & Co. in Rahway, NJ is seeking a CDM Trial Lead to oversee end-to-end data management for assigned studies, ensuring quality, integrity, and regulatory compliance.

You will coordinate cross-functional teams, manage data collection design, and drive data standards adoption across the trial lifecycle. The role requires deep knowledge of CDISC standards, GCP, risk-based quality management, and strong leadership to guide DM deliverables and TMF readiness.

Qualifications

• Minimum 10 years of directly relevant experience in data management, clinical trial operations or related field.
• Non-Degree/Associate or Bachelor’s degree with extensive data management experience if applicable.
• Advanced degree preferred with strong data management background.

Responsibilities

• Lead end-to-end data management activities from start-up through database lock and archival according to SOPs, ICH-GCP, and protocol requirements.
• Oversee data collection design and review across data types; translate protocol into data deliverables and tools.
• Ensure data integrity across multiple sources including EDC, DHT, eCOA, and external data.
• Own risk-based data quality oversight; identify trends, implement mitigations, and escalate when needed.
• Oversee data acquisition, integration activities, and data cleaning validation specifications.
• Ensure protocol-aligned laboratory data setup and support, including normal ranges and documentation.
• Develop and maintain core DM deliverables (DMP, DVP, eCRFs, UAT, CDISC mappings) and TMF readiness.
• Lead UAT and change control for relevant systems; ensure traceability and approvals.
• Represent data management in governance forums and cross-functional meetings.

Skills

Adaptability

Clinical Data Management

CDISC standards

GCDMP

GCP

Data Standards

Data Validation

Data Integrity

Data Quality Assurance

Data Reporting

Influencing Skills

Project Management

Delivery Management

Clinical Data Management Platforms

EDC systems

Validation & UAT

Education

Non-Degree or Associates Degree

Bachelor's Degree

Advanced Degree (Masters or Doctorate)

Tools

EDC systems

CDISC/CDASH/SDTM tooling

Job description

Merck & Co. in Rahway, NJ is seeking a CDM Trial Lead to oversee end-to-end data management for assigned studies, ensuring quality, integrity, and regulatory compliance.

You will coordinate cross-functional teams, manage data collection design, and drive data standards adoption across the trial lifecycle. The role requires deep knowledge of CDISC standards, GCP, risk-based quality management, and strong leadership to guide DM deliverables and TMF readiness.