Senior/Associate Director, Clinical Data Manager - Remote

Eliassen Group; Lincoln (NE); Remote; USD 90,000 - 96,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401k with company match

Life Insurance

Job summary

Eliassen Group is seeking a Senior Manager or Associate Director-level Clinical Data Manager for a 1-year extendable engagement. The role will lead data management activities for an assigned cardiovascular trial, including CRF/eCRF design, EDC development, external data processing, and regulatory reporting alignment.

The position offers a remote engagement with potential hybrid options in Princeton, NJ or San Francisco, CA.

Qualifications

• 5+ years of clinical data management at the manager level.
• Sponsor-side CRO oversight experience for Phase III studies.
• Biotech or pharmaceutical industry background; cardiovascular experience preferred.

Responsibilities

• Lead end-to-end clinical data management for the cardiovascular trial in line with SOPs, GCP, and ICH guidelines.
• Review study protocol and develop or review database definition files.
• Oversee CRF/eCRF creation, Data Validation Plans, and Edit Check Specifications.
• Perform or oversee UAT of eCRFs and edit checks for development databases.
• Manage change requests after database go-live.
• Review CRF/eCRF for outsourced trials and generate queries as needed.
• Oversee Data Transfer Agreements with vendors and ensure data integrity.
• Ensure data query resolution and SAE reconciliation for outsourced trials.
• Review data listings and lead cross-functional data reviews for safety signals and regulatory reporting.

Skills

Clinical Data Management

Leadership

CRO Oversight

Cardiovascular

Education

Bachelor's Degree

Tools

EDC Systems

Job description

Eliassen Group is seeking a Senior Manager or Associate Director-level Clinical Data Manager for a 1-year extendable engagement. The role will lead data management activities for an assigned cardiovascular trial, including CRF/eCRF design, EDC development, external data processing, and regulatory reporting alignment.

The position offers a remote engagement with potential hybrid options in Princeton, NJ or San Francisco, CA.