Remote Senior Clinical Data Manager – Cardiovascular Trials

Eliassen Group; Juneau (AK); Remote; USD 185,976,000 - 199,752,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) 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 leads data management for an assigned cardiovascular clinical trial, including CRF/eCRF design, EDC development, external data processing, medical coding oversight, data review, and close/lock in alignment with SOPs, GCP, and ICH Guidelines.

Remote or hybrid options may be available in Princeton, NJ or San Francisco, CA.

Qualifications

• 5+ years in clinical data management at manager level.

Responsibilities

• Lead end-to-end clinical data management for cardiovascular trial in accordance 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 edits 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 specs, Data Management Plans, and Manual Review Guidelines for outsourced trials.
• Oversee Data Transfer Agreements with ancillary vendors.
• Ensure query resolution for outsourced trials and SAE reconciliation.
• Review data listings and manage cross-functional data reviews to identify safety signals and support regulatory reporting (DSUR/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

Data management leadership

CRF/eCRF design

EDC development

UAT testing

Regulatory reporting

Cross-functional collaboration

GCP/ICH compliance

Education

Bachelor's degree

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 an assigned cardiovascular clinical trial, including CRF/eCRF design, EDC development, external data processing, medical coding oversight, data review, and close/lock in alignment with SOPs, GCP, and ICH Guidelines.

Remote or hybrid options may be available in Princeton, NJ or San Francisco, CA.