Senior Clinical Data Manager - Remote Cardio Trials

Eliassen Group; Austin (TX); Remote; USD 90,000 - 96,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

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, including CRF/eCRF design, EDC development, external data processing, coding oversight, data review, and timely database close in alignment with SOPs, GCP, and ICH guidelines.

The engagement may be remote or hybrid in Princeton, NJ or San Francisco, CA.

Qualifications

• At least 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.
• Ability to work fully remote with proximity to Princeton, NJ or San Francisco, CA.

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 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

CDM leadership

GCP/ICH familiarity

EDC systems

Data review

Education

Bachelor's or higher

Tools

EDC platforms

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, including CRF/eCRF design, EDC development, external data processing, coding oversight, data review, and timely database close in alignment with SOPs, GCP, and ICH guidelines.

The engagement may be remote or hybrid in Princeton, NJ or San Francisco, CA.