Remote Senior Clinical Data Manager – Cardiovascular Trials

Eliassen Group; San Juan (PR); Remote; USD 185,976,000 - 199,752,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k with company matching

Life insurance

Job summary

Our client, a small clinical-stage biotech focused on cardiovascular medicines, seeks 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 clinical trial, including CRF/eCRF design, EDC database development, external data processing, medical coding oversight, data review, and database close/lock in alignment with SOPs, GCP, and ICH Guidelines.

Qualifications

• Minimum 5 years’ clinical data management experience at a managerial level.
• Sponsor-side CRO oversight experience for Phase III studies.
• Biotech or pharmaceutical industry background required.
• 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 line with SOPs, GCP, and ICH guidelines.
• Review study protocol and develop or review database definition files.
• Oversee CRFs/eCRFs, Data Validation Plans, and Edit Check Specifications.
• Perform or oversee UAT of eCRFs and edit checks for databases under 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 SAE reconciliation.
• Review data listings and cross-functional data reviews to identify safety signals for regulatory reporting.
• Provide Data Management summary 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 decisions.

Skills

Clinical Data Management

Leadership

Remote work

Education

Bachelor's degree or higher

Tools

EDC

CRF/eCRF Design

Data Validation Plans

Data Transfer Agreements

Job description

Our client, a small clinical-stage biotech focused on cardiovascular medicines, seeks 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 clinical trial, including CRF/eCRF design, EDC database development, external data processing, medical coding oversight, data review, and database close/lock in alignment with SOPs, GCP, and ICH Guidelines.