Senior CDM Trial Lead: End-to-End Data Management

MSD Malaysia; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical benefits

Retirement plan (401(k))

Paid holidays

Job summary

MSD Malaysia in Rahway, NJ is seeking a CDM Trial Lead to ensure end-to-end data management across studies, delivering quality, integrity, and compliance with GDMS standards and regulatory requirements. You will lead data collection design, develop validation and query strategies, supervise data review across sources such as EDC, eCOA, labs, and imaging, and mentor CDMs and external specialists.

Strong CDISC knowledge and RBQM are essential to success in this global role.

Qualifications

• Minimum 8–10 years of directly relevant experience in data management or clinical trial operations.
• Advanced degree preferred in Life Sciences, Nursing, Pharmacy, or Data/IT.
• Strong knowledge of CDISC standards (CDASH/SDTM/Define-XML) and regulatory requirements.
• Experience with RBQM, privacy rules, and 21 CFR Part 11 compliance.

Responsibilities

• Lead end-to-end data management activities from study start-up through database lock and archival.
• Develop data validation and query strategies for sites and vendors across multiple data types (EDC, eCOA, labs, imaging).
• Oversee data integration from diverse sources and ensure data integrity and traceability.
• Mentor and train Clinical Data Managers (CDMs) and External Data Specialists (EDS) and drive knowledge sharing.

Skills

Clinical Data Management

Influencing Skills

Interpersonal Relationships

Project Leadership

Risk Management

Strategic Thinking

Team Organization

Education

Bachelor's degree or higher in Life Sciences / IT / Medical Technology

Job description

MSD Malaysia in Rahway, NJ is seeking a CDM Trial Lead to ensure end-to-end data management across studies, delivering quality, integrity, and compliance with GDMS standards and regulatory requirements. You will lead data collection design, develop validation and query strategies, supervise data review across sources such as EDC, eCOA, labs, and imaging, and mentor CDMs and external specialists.

Strong CDISC knowledge and RBQM are essential to success in this global role.