Remote Senior Clinical Data Manager for Cardiovascular Trials

Eliassen Group; United States; Remote; Confidential; 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 or Associate Director level Clinical Data Manager for a 1-year extendable engagement in the cardiovascular space. The role involves leading data management for an assigned trial, including CRF/eCRF design, EDC development, data validation, and regulatory deliverables, with remote or hybrid options in Princeton, NJ or San Francisco, CA.

Ideal candidates have 5+ years of CDM experience, CRO oversight on Phase III, and a biotech/pharma background, with a degree

Qualifications

• 5+ years in clinical data management at a manager level
• Sponsor-side CRO oversight experience for Phase III studies
• Biotech or pharmaceutical industry background
• Cardiovascular experience preferred
• Degree preferred and able to work remote (proximity to Princeton, NJ or San Francisco, CA)

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.

Job description

Eliassen Group is seeking a Senior or Associate Director level Clinical Data Manager for a 1-year extendable engagement in the cardiovascular space. The role involves leading data management for an assigned trial, including CRF/eCRF design, EDC development, data validation, and regulatory deliverables, with remote or hybrid options in Princeton, NJ or San Francisco, CA.

Ideal candidates have 5+ years of CDM experience, CRO oversight on Phase III, and a biotech/pharma background, with a degree