Senior/Associate Director, Clinical Data Manager - Remote

Eliassen Group; Topeka (KS); Remote; USD 90,000 - 96,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company matching

Life insurance

Remote work

Job summary

Eliassen Group is seeking a Senior Manager or Associate Director level Clinical Data Manager for a 1-year extendable engagement focused on cardiovascular trials. You will lead data management activities including CRF/eCRF design, EDC development, external data processing, data review, and database close/lock in alignment with SOPs, GCP, and ICH Guidelines.

The role offers remote or hybrid work in Princeton, NJ or San Francisco, CA with a W2 benefits package including medical, dental, vision,

Qualifications

• At least 5 years of clinical data management experience at manager level.
• Sponsor-side CRO oversight experience for Phase III studies.
• Biotech/pharma industry background.
• Cardiovascular experience preferred.
• Degree preferred.

Responsibilities

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

Data management

GCP

ICH Guidelines

eCRF

Education

Bachelor's degree

Tools

EDC

Job description

Eliassen Group is seeking a Senior Manager or Associate Director level Clinical Data Manager for a 1-year extendable engagement focused on cardiovascular trials. You will lead data management activities including CRF/eCRF design, EDC development, external data processing, data review, and database close/lock in alignment with SOPs, GCP, and ICH Guidelines.

The role offers remote or hybrid work in Princeton, NJ or San Francisco, CA with a W2 benefits package including medical, dental, vision,