• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Sr. Clinical Data Manager

Job Number: 34820

Location:

Job Description

The Senior Clinical Data Manager oversees clinical data management activities, ensuring quality and accuracy in clinical trial databases.

Responsibilities

  • Coordinate data management activities from protocol initiation to database lock.
  • Provide oversight for outsourced projects.
  • Support CRF design and validation, perform user acceptance testing, and monitor project progress.
  • Conduct data cleaning and QC activities, prepare data transfer agreements, and author database lock documentation.
  • Provide data management timelines, contribute to process improvement, and mentor junior Data Managers.

Required Skills

  • Bachelor's degree in a related health profession or research compliance field.
  • 5+ years of data management experience in a CRO or sponsor company environment.
  • Knowledge of CDISC/CDASH standards and EDC systems.
  • Familiarity with medical terminology and coding dictionaries.
  • Understanding of ICH, FDA, and GCP regulations in data management.
  • Experience in biotech, pharmaceutical, or medical device industries preferred.
  • Strong scientific background in clinical trials and regulatory compliance.
  • Proven ability to initiate process improvement independently.
  • Track record of success in dynamic organizations and collaborative environments.
  • Highly organized with excellent communication skills.
  • Ethical and professional with a passion for quality results.

 

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