QC Specialist

The role

Quality Control Specialists perform quality control activities for Biometrics client deliverables. They maintain project level perspective and act as quality control subject matter experts.

What you will do

• Perform quality control activities of Biometrics client 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
• Develop and lead execution of training and knowledge transfer opportunities for quality control team
• Inform the Manager of training issues, project activities, quality issues and timelines
• Collaborate with the project team to ensure deliverables are completed on time with high quality
• Other duties as assigned

Required qualifications

• Excellent knowledge of English
• Minimum 3-5 years in Pharmaceutical/Biotechnology industry or equivalent
• Excellent verbal and written communication skills
• Detail oriented
• Ability to multitask with strong prioritization, planning and organization skills
• Excellent team player
• Extensive validation experience of eCRFs, Edit Checks, Custom Functions, Data Management reports
• Good understanding of Database structures and Programming languages
• Proficiency in Microsoft Office Applications, specifically MS Word, MS Excel and PowerPoint

Nice to have

• Four-year college degree or higher
• Analytic discipline (Computer Science or Health related field)
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and industry standards (CDASH, SDTM)
• Experience performing quality control activities of clinical trial deliverables
• Extensive knowledge of Medidata Rave EDC platform and other modules of Rave
• Familiarity with Databases: SQL Server, Oracle

About the company

eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. The elluminate platform and digital data services provide clients self-service access to data and advanced analytics.