
201 - 500 employees
Founded 2020
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.
🔥 6 minutes ago
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201 - 500 employees
Founded 2020
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.
• Execute validation activities for computerized systems and software in compliance with GxP, 21 CFR Part 11, and applicable regulatory requirements • Develop and maintain validation plans, test scripts, traceability matrices, summary reports, and release documentation • Partner with IT, Quality Assurance, business stakeholders, and external vendors to define validation strategies and deliver projects • Coordinate and oversee validation testing activities • Manage defects, deviations, and incidents, including triage, resolution tracking, and closure documentation • Facilitate review, approval, execution, and post-execution management of validation and qualification documentation • Train and support project teams on validation procedures, tools, documentation standards, and best practices • Guide change management for validated systems • Stay current with evolving regulatory requirements and industry standards
• Bachelor's degree in Computer Science, Information Technology, Engineering, Software Development, or a related field with 3-5 years of relevant experience, or equivalent combination of education and experience • Experience validating GCP-regulated computerized systems and software • Experience ideally within pharmaceutical, biotechnology, medical device, or other highly regulated industries • Strong understanding of quality system principles, including validation, documentation, change control, training, and audit readiness • Ability to collaborate in cross-functional and matrixed environments • Ability to build relationships with internal stakeholders, business partners, and external vendors • Excellent written and verbal communication skills • Ability to document, present, and explain technical and compliance-related information clearly • Experience working within Software Development Lifecycle (SDLC) processes • Familiarity with automated testing tools and enterprise validation technologies considered an asset • Resume must be submitted in English
• Bonus • Education Reimbursement program for full-time employees • Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility) • One time office setup allowance • Working while visiting program – up to 4 weeks per year • Flexible Summer Hours Program from May – September • Employee referral incentive • Full-time employees become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment • Optional formal mentorship program (Alimentorship) • Country/region annual social events in person • Leadership development programs for people leaders in accordance with seniority • Social committee and other optional initiatives • Additional benefits may be available depending on the country of employment and local policies and eligibility • Flexible remote work arrangement
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