• , US

Company:  Confidential

Job Title: Sr. Clinical Data Manager

Job Number: 78521

Location: , US

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.

Application Deadline: 2024-06-03

 

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