Lead Clinical Data Manager - CDISC/SDTM Expert

Downtown Boulder Partnership; Princeton (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

TK-CHAIN LLC in Princeton, NJ seeks a Principal Clinical Data Manager to lead data management activities across clinical studies. The role entails coordinating with project management, clinical monitoring, biostatistics and external partners to ensure data integrity and regulatory compliance.

Responsibilities include EDC/eCRF design, validation planning, data cleaning, UAT coordination and tracking of data-related timelines.

Qualifications

• Experience with ICH-GCP(R2) and regulatory requirements.
• Strong data management and statistical collaboration skills.
• CDISC standards (CDASH, SDTM) experience required.

Responsibilities

• Serve as primary DM contact with internal and external stakeholders throughout the study.
• Review study documents and assist with eCRF design and validation.
• Develop and maintain DM documents (DMP, eCRF, DVP) and data transfer agreements.
• Coordinate UAT and training of EDC users.
• Validate data, ensure accuracy, integrity and completeness.
• Produce project metrics and status updates for the team.

Skills

ICH-GCP

GDPR/HIPAA

CDISC CDASH SDTM

Data management

Education

B.S. in life science/healthcare

Tools

Relational databases

eCRF platforms

Job description

TK-CHAIN LLC in Princeton, NJ seeks a Principal Clinical Data Manager to lead data management activities across clinical studies. The role entails coordinating with project management, clinical monitoring, biostatistics and external partners to ensure data integrity and regulatory compliance.

Responsibilities include EDC/eCRF design, validation planning, data cleaning, UAT coordination and tracking of data-related timelines.