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. We have shared our story, now we look forward to learning yours!

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. Bring your authentic self, you are welcome here!

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.