Senior CDM Trial Lead: Data Quality & Delivery

Merck; Upper Gwynedd Township (Montgomery County); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck is seeking a Clinical Data Management Trial Lead to provide end-to-end data management for assigned studies, ensuring quality, integrity, and GDMS/regulatory compliance. You will partner across functions to drive data strategy, risk assessment, and process improvements, including data standards and trial master file readiness.

The role requires leadership in data acquisition, integration, validation, and oversight of key deliverables while guiding teams through complex data flows, audits,

Qualifications

• Non‑Degree or associate's degree (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / IT).
• Bachelor's Degree (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / IT).
• Advanced Degree (Masters or Doctorate) (preferred in those fields).

Responsibilities

• Lead end-to-end clinical data management activities from study start-up through database lock and archival.
• Oversee data collection design and review across all data types and ensure translation of protocol into data management deliverables.
• Ensure data integrity across sources and environments including EDC, eCOA, and external data.
• Own risk-based data quality oversight; identify trends, perform root‑cause analysis, implement mitigations.
• Oversee data acquisition/integration activities and validation specifications.
• Ensure protocol-aligned laboratory data setup and compliance with normal ranges.
• Develop, review, approve, and maintain core DM deliverables (DMP, DVP, eCRFs, UAT, etc.).
• Lead UAT and change control across systems and data flows, ensuring traceability.

Skills

Clinical Data Management

Cross-functional collaboration

Risk management

Project leadership

Education

Non‑Degree or associate's degree (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / IT)

Bachelor's Degree (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / IT)

Advanced Degree (Masters or Doctorate) (preferred)

Tools

EDC systems

eCOA

CDISC/CDASH/SDTM Define-XML

Job description

Merck is seeking a Clinical Data Management Trial Lead to provide end-to-end data management for assigned studies, ensuring quality, integrity, and GDMS/regulatory compliance. You will partner across functions to drive data strategy, risk assessment, and process improvements, including data standards and trial master file readiness.

The role requires leadership in data acquisition, integration, validation, and oversight of key deliverables while guiding teams through complex data flows, audits,