Hybrid Clinical Data Lead for Oncology Trials

SystImmune; Princeton (NJ); Hybrid; USD 100,000 - 170,000; Full time

Benefits offered by this job

100% paid employee premiums for health

401(k) plan with company match

15 PTO days per year

11 paid holidays

Job summary

SystImmune in Princeton, NJ is seeking a Clinical Data Manager to oversee data management for multiple clinical trials. You will design, configure, and test databases, lead DM documents, and drive data quality across studies.

The role requires coordinating with CROs, managing data delivery, and performing SAS/R analyses as needed. A BS in a life sciences field with 4+ years of DM experience and knowledge of CDISC/GCP is expected.

Qualifications

• BA or BS with at least 4 years in data management for clinical trials.
• Knowledge of GCP, CDISC standards (CDASH/SDTM/ADaM), FDA/ICH guidelines.
• Experience with clinical EDC systems and data management lifecycle.
• Strong attention to detail and cross-functional collaboration.

Responsibilities

• Lead all data management lifecycle activities from study start-up to close-out.
• Develop DM documents (DMP, CRFs, edits) and oversee data cleaning.
• Coordinate with CROs/Vendors and ensure on-time DM deliverables.
• Run SAS and/or R programs, review logs, and generate listings.
• Ensure QA and data integrity across trials.

Skills

SAS programming

GCP standards

CDISC standards

DM lifecycle expertise

Veeva/Medidata experience

Education

Bachelor's degree (BA/BS)

Tools

Medidata Rave

Veeva EDC

SAS

R

RTSM / eCOA

Job description

SystImmune in Princeton, NJ is seeking a Clinical Data Manager to oversee data management for multiple clinical trials. You will design, configure, and test databases, lead DM documents, and drive data quality across studies.

The role requires coordinating with CROs, managing data delivery, and performing SAS/R analyses as needed. A BS in a life sciences field with 4+ years of DM experience and knowledge of CDISC/GCP is expected.