QC Specialist

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