Senior Clinical Data Manager (Remote) - Cardio Trials

Eliassen Group; Boise (ID); Remote; USD 90,000 - 96,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401k with company matching

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, data reviews, and close/lock in line with SOPs, GCP, and ICH Guidelines.

The engagement may be remote or hybrid in Princeton, NJ or San Francisco, CA. Due to client requirements, applicants must be willing and able to work on a w2 basis.

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.
• Degree preferred.

Responsibilities

• Lead end-to-end clinical data management for assigned cardiovascular clinical 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 Management

CRO Oversight

Biotech/Pharma

Cardiovascular Experience

Degree

Education

Bachelor's degree preferred

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, data reviews, and close/lock in line with SOPs, GCP, and ICH Guidelines.

The engagement may be remote or hybrid in Princeton, NJ or San Francisco, CA. Due to client requirements, applicants must be willing and able to work on a w2 basis.