Senior Clinical Data Manager – Cardiovascular (Remote)

Eliassen Group; Helena (MT); Remote; USD 90,000 - 96,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with match

Sick time

Job summary

Eliassen Group seeks a Senior Manager or Associate Director level Clinical Data Manager for a 1-year extendable engagement focused on cardiovascular trials. The role leads end-to-end data management activities, including CRF/eCRF design, EDC development, external data processing, medical coding oversight, data review, and database close/lock in alignment with SOPs, GCP and ICH guidelines.

The engagement is remote or hybrid (Princeton, NJ or San Francisco, CA), with W2 employment and a benefits

Qualifications

• 5+ years of clinical data management at the manager level.
• Sponsor-side CRO oversight experience for Phase III studies.
• Cardiovascular clinical trial experience preferred.
• Remote work with proximity preference to Princeton, NJ or San Francisco, CA.
• Bachelor's degree preferred.

Responsibilities

• Lead end-to-end clinical data management for assigned cardiovascular trial.
• Review study protocol and develop or review database definitions.
• 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.
• 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.

Education

Bachelor's degree

Tools

EDC systems

Job description

Eliassen Group seeks a Senior Manager or Associate Director level Clinical Data Manager for a 1-year extendable engagement focused on cardiovascular trials. The role leads end-to-end data management activities, including CRF/eCRF design, EDC development, external data processing, medical coding oversight, data review, and database close/lock in alignment with SOPs, GCP and ICH guidelines.

The engagement is remote or hybrid (Princeton, NJ or San Francisco, CA), with W2 employment and a benefits