Lead Clinical Data Management for Oncology Trials

SystImmune, Inc.; Redmond (WA); On-site; USD 100,000 - 170,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid time off

Holidays

Long-term disability

Dental/Vision

Job summary

SystImmune Inc. in Redmond, WA, is seeking a Clinical Data Manager (CDM) to design, configure, and test clinical database systems for multiple trials. The role involves data review, data management, reporting, and oversight of CROs and vendors to ensure study deliverables are met.

The CDM will lead data management activities from study start-up through database lock, develop DM documents, perform data cleaning, and support regulatory deliverables in a fast-paced oncology-focused environment.

Qualifications

• BA or BS with a minimum of 4 years of relevant experience.
• Technologically savvy; quickly picks up new standards, tools or software.
• Experience with Clinical EDC systems (e.g., Medidata Rave, Veeva EDC).
• SAS programming experience.
• Experience with Lab Data management (PK, PD, Biomarkers).
• Knowledgeable in GCP, CDISC (CDASH, SDTM, ADaM), FDA/ICH, and GCDMP.

Responsibilities

• Leads DM lifecycle activities from start-up to close-out.
• Develop DM documents (DMPs, CRFs, CRF guidelines) and data review plans.
• Lead data cleaning and reconciliation with cross-functional input.
• Manage data deliverables and database locks with high quality and efficiency.
• Foster collaboration with study team representatives across functions.
• Oversee DM projects and vendor/CRO coordination to meet deliverables.
• Perform medical coding with CROs and Medical Monitors as needed.
• Run SAS or R programs and generate data outputs for listings.

Skills

DM lifecycle

SAS programming

EDC systems

CDISC standards

GCP knowledge

PM skills

Vendor/CRO management

RTSM/eCOA

Education

BA or BS + 4+ years

Tools

Medidata Rave

Veeva EDC

SAS

eCOA/ePRO

RTSM

Job description

SystImmune Inc. in Redmond, WA, is seeking a Clinical Data Manager (CDM) to design, configure, and test clinical database systems for multiple trials. The role involves data review, data management, reporting, and oversight of CROs and vendors to ensure study deliverables are met.

The CDM will lead data management activities from study start-up through database lock, develop DM documents, perform data cleaning, and support regulatory deliverables in a fast-paced oncology-focused environment.