QC Specialist

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