Remote Senior Clinical Data Manager - Cardiovascular Trials

Eliassen Group; Augusta (ME); Remote; USD 90,000 - 96,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k with 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 leads data management for a cardiovascular trial, covering CRF/eCRF design, EDC development, external data processing, and data close/lock in line with SOPs, GCP, and ICH guidelines.

Remote/flexible location with potential hybrid options in Princeton, NJ or San Francisco, CA.

Qualifications

• 5+ years of clinical data management experience at the manager level.
• Sponsor-side CRO oversight experience for Phase III studies.
• Biotech or pharmaceutical industry background.
• Cardiovascular experience preferred.
• Degree preferred.
• Ability to work fully remote with proximity to Princeton, NJ or San Francisco, CA.

Responsibilities

• Lead end-to-end clinical data management for assigned cardiovascular trial in accordance with SOPs, GCP, and ICH Guidelines.
• Review study protocol and develop or review database definition files.
• Oversee creation of CRFs/eCRFs, Data Validation Plans, and Edit Check Specifications.
• Perform or oversee UAT of eCRFs and edit checks for databases in development.
• Manage change requests after database go-live.
• Review CRF/eCRF for outsourced trials and generate queries as needed.
• Review edit check specifications, Data Management Plans, and Manual Review Guidelines for outsourced trials.
• Oversee Data Transfer Agreements with ancillary vendors.
• Ensure query resolution for outsourced trials and perform SAE reconciliation.
• Review data listings and manage cross-functional data reviews to identify safety signals and support regulatory reporting, including DSUR and SUSAR.
• Provide Data Management summary reports and ad hoc reports to management and Clinical Operations.
• Ensure database close and lock at trial end.
• Resolve complex data issues to support interim analyses and timely decision-making.

Skills

Clinical Data Mgmt

GCP

ICH Guidelines

Education

Bachelor’s or Master’s degree

Tools

eCRF

EDC

Job description

Eliassen Group is seeking a Senior Manager or Associate Director-level Clinical Data Manager for a 1-year extendable engagement. The role leads data management for a cardiovascular trial, covering CRF/eCRF design, EDC development, external data processing, and data close/lock in line with SOPs, GCP, and ICH guidelines.

Remote/flexible location with potential hybrid options in Princeton, NJ or San Francisco, CA.