Remote Senior Clinical Data Manager Cardiovascular Trials

Eliassen Group

Columbia (SC)

On-site

USD 135,000 - 146,000

Full time

6 days ago
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Benefits offered by this job

Medical
Dental
Vision
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 will lead data management activities for an assigned cardiovascular clinical trial, including CRF/eCRF design, EDC database development, external data processing, medical coding oversight, data review, and database close/lock in alignment with SOPs, GCP, and ICH Guidelines.

Qualifications

  • Minimum 5 years of clinical data management at a managerial level.
  • Experience overseeing sponsor-side CRO operations for Phase III trials.
  • Background in biotech or pharmaceutical industries.
  • Cardiovascular experience preferred.
  • Degree preferred.

Responsibilities

  • Lead end-to-end clinical data management for the cardiovascular trial per SOPs/GCP/ICH.
  • Review protocol and develop or review database definitions.
  • Oversee CRF/eCRF, DVP, and edit check specs development.
  • Manage UAT of eCRFs and edits for databases in development.
  • Ensure timely data reviews and management reporting.

Skills

Clinical data management
Manager level experience
Sponsor-side CRO oversight
Cardiovascular experience
Remote work

Education

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 will lead data management activities for an assigned cardiovascular clinical trial, including CRF/eCRF design, EDC database development, external data processing, medical coding oversight, data review, and database close/lock in alignment with SOPs, GCP, and ICH Guidelines.

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