Remote Senior Clinical Data Manager - Cardiovascular

Eliassen Group; Hagåtña (GU); Remote; USD 135,000 - 146,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Life insurance

Job summary

Eliassen Group is seeking a Senior Manager/Associate Director level Clinical Data Manager to lead data management for a cardiovascular trial. The role involves CRF/eCRF design, EDC development, data processing, coding oversight, data review, and close/lock processes in line with SOPs, GCP, and ICH guidelines.

The engagement is remote with possible hybrid options in Princeton, NJ or San Francisco, CA. W2 consultants receive a comprehensive benefits package including medical, dental, vision, 401k

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 preference to Princeton, NJ or San Francisco, CA.

Responsibilities

• Lead end-to-end clinical data management for the cardiovascular trial in accordance with SOPs, GCP, and ICH Guidelines.
• Review protocol and develop or review database definitions and data specs.
• Oversee CRF/eCRF creation and Data Validation Plans; manage edits and queries.
• Perform or oversee UAT of eCRFs and edit checks; manage post-go-live changes.
• Ensure timely data delivery and support regulatory reporting including DSUR/SUSAR.

Skills

Clinical data management

Management experience

CRO oversight

Cardiovascular experience

Education

Degree preferred

Tools

eCRF/EDC design

SOP/GCP/ICH knowledge

Job description

Eliassen Group is seeking a Senior Manager/Associate Director level Clinical Data Manager to lead data management for a cardiovascular trial. The role involves CRF/eCRF design, EDC development, data processing, coding oversight, data review, and close/lock processes in line with SOPs, GCP, and ICH guidelines.

The engagement is remote with possible hybrid options in Princeton, NJ or San Francisco, CA. W2 consultants receive a comprehensive benefits package including medical, dental, vision, 401k