QC Specialist

About the Company

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials.

Responsibilities

• Perform quality control activities including documentation review and testing of Rave EDC and Data management deliverables
• Participate in the design and development of quality control procedures
• Manage documentation created during the QC process
• Liaise with study teams and other staff to fulfill job responsibilities
• Develop and lead execution of training and knowledge transfer opportunities for the quality control team
• Collaborate with the project team to ensure deliverables are completed on time with high quality

Requirements

• Minimum 3-5 years in Pharmaceutical/Biotechnology industry or equivalent
• Four-year college degree or higher, preferably in an analytic discipline like Computer Science or a health-related field
• Extensive validation experience of eCRFs, Edit Checks, Custom Functions, and Data Management
• Proficiency in Microsoft Office Applications (MS Word, MS Excel, PowerPoint)
• Excellent English communication skills
• Strong detail orientation and multitasking abilities

Preferred Qualifications

• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology
• Familiarity with industry standards such as CDASH and SDTM
• Extensive knowledge of Medidata Rave EDC platform and other Rave modules
• Familiarity with SQL Server or Oracle databases