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 responsible for performing quality control activities associated with Professional Services deliverables

Key Tasks & Responsibilities

Perform quality control activities (i e,

documentation review, testing) of Professional Service deliverables including eCRFs, Data Validation Specifications, Data Extracts, Data Integrations, Data Mapping, and Custom Reports

Participate in the design and development of quality control procedures

Manage documentation created during the QC process

Collaborate with the project team to ensure the deliverables are completed on time with high quality

Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines and procedures

Other duties as assigned

CANDIDATE’S PROFILE

Education & Experience

Bachelor’s degree or equivalent work experience preferred

Excellent knowledge of English

Professional Skills

3+ years in Pharmaceutical/Biotechnology industry or equivalent preferred

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

Proficiency in Microsoft Office Applications, specifically MS Word and MS Excel

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare

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eClinical Solutions is a people first organization

Our inclusive culture values the contribution that diversity brings to our business

We celebrate individual experiences that connect us and that inspire innovation in our community

Our team seeks out opportunities to learn, grow and continuously improve

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We are proud to be an equal opportunity employer that values diversity

Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need