About the role
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. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
OVERVIEW
Quality Control Specialists are operationally responsible for performing quality control activities associated with Biometrics client’s deliverables. Quality Control Specialists will maintain project level perspective, focus, and communicate effectively as the quality control subject matter expert.
KEY TASKS & RESPONSIBILITIES
- Perform quality control activities (i.e. documentation review, testing) of Biometrics client’s Rave EDC and Data management deliverables including eCRFs, Data Validation Specification checks, Custom functions, Data Extracts, Data Integrations, Data Mapping, Custom Data Management Reports and listings
- 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 and activities
- 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 as directed
- Collaborate with the project team to ensure the deliverables are completed on time with high quality
- Other duties as assigned
CANDIDATE’S PROFILE
Education/Language
- Four-year college degree or higher preferred, analytic discipline a plus (Computer Science or Health related field)
- Excellent knowledge of English
Professional Skills & Experience
- Minimum 3-5 years in Pharmaceutical/Biotechnology industry or equivalent
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and industry standards (CDASH, SDTM) preferred
- Experience performing quality control activities of clinical trial deliverables preferred
- Excellent verbal and written communication skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
- Excellent team player
Technical Skills & Experience
- Extensive knowledge of Medidata Rave EDC platform and other modules of Rave preferred
- Familiarity with Databases: SQL Server, Oracle highly preferred
- Extensive validation experience of eCRFs, Edit Checks, Custom Functions, Data Management
reports and good understanding of Database structures and Programming languages
- Proficiency in Microsoft Office Applications, specifically MS Word, MS Excel and PowerPoint