--- title: 'Clinical Operations Lead at Alimentiv' canonical: 'https://feeny.ai/job/clinical-operations-lead-alimentiv-budapest-2ykmmfdbzy53' type: 'job' last_seen: '2026-10-18' --- # Clinical Operations Lead at Alimentiv - **Company:** Alimentiv - **Location:** Budapest, Hungary - **Employment:** full-time - **Work type:** remote - **Posted:** 2024-12-23 - **Last confirmed live:** 2026-10-18 - **Apply:** https://jobs.lever.co/alimentiv-2/3e3693cf-bcf6-4ca8-a28d-4272137282b5 ## Job description Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development. We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there. If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you! Job Overview As a Clinical Operations Lead, you will provide clinical operations oversight for projects at a regional or global level, ensuring study deliverables, CRA activities and investigator sites are managed in accordance with the protocol, monitoring plan, ICH-GCP guidelines and applicable local regulations. You will act as a key liaison between CRAs and the clinical project team, providing operational guidance, training and oversight throughout the study. The role will also support site start-up and feasibility, recruitment and enrolment strategies, monitoring performance, issue escalation and corrective actions, while contributing to study planning, documentation and overall project delivery. ## Key Responsabilities Provide oversight of regional CRAs and investigator sites, ensuring compliance with study protocols, monitoring plans, ICH-GCP, local regulations and study timelines. Conduct co-monitoring and CRA assessment visits as required, supporting site and CRA performance and ensuring monitoring standards are maintained. Proactively monitor site and country performance, including recruitment, data collection, document collection and TMF activities, and communicate progress to the clinical project team. Oversee regional site start-up and feasibility activities and support vendor management activities where required. Review monitoring visit reports for quality, compliance and appropriate site management, ensuring project deliverables are completed accurately and on time. Serve as a key point of contact for regional CRAs, providing study-specific guidance, resolving issues and escalating matters to the Project Manager or relevant functions when appropriate. Provide training and mentoring to CRAs on study procedures, clinical plans, guidelines and timelines, and ensure study-specific training is completed and documented. Participate in Sponsor meetings and CRA calls, providing updates on country and site performance and operational progress. Develop and implement enrolment and recruitment strategies and create study tools, training materials, monitoring plans and other clinical operations documentation. Support the clinical project team with study deliverables, presentations, site management activities, protocol deviations, financial project activities and other operational objectives as required. ## Skills & Qualifications 4–6 years of relevant clinical research experience required, with 7–9 years preferred. Minimum 3 years of CRA experience, with strong hands-on understanding of clinical monitoring activities. Post-secondary certificate/diploma required; a Bachelor’s degree in Health Sciences, Life Sciences, Nursing or a related discipline is preferred. Strong understanding of ICH-GCP, local regulations, IRB/EC requirements and Investigator responsibilities as they relate to clinical monitoring. Experience working with EDC systems and clinical research documentation. Strong understanding of clinical trial processes, site management, monitoring activities and study performance metrics. Excellent written and verbal communication skills, with the ability to effectively communicate with CRAs, Sponsors, investigators and cross-functional teams. Strong organisational, interpersonal and project coordination skills, with the ability to manage multiple priorities and deadlines in a dynamic environment. Highly proactive, detail-oriented, task-driven and organised, with strong problem-solving and critical-thinking abilities. Proficiency in Microsoft Office and demonstrated ability to prepare high-quality reports, presentations and clinical research documentation. SoCRA and/or ACRP certification/designation is an advantage. ## What We Offer In addition, as an Alimentiv Employee, you’re also eligible for the following programs: - Education Reimbursement program for full-time employees - Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility) - One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.) - Working while visiting program – up to 4 weeks per year! - Flexible Summer Hours Program from May – September - Employee referral incentive – we know great people know other great people, and we think that warrants recognition! - Full-time employees also 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 your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team! Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility. Our Services - End-to-end GI clinical trial services, from protocol design through submission support - Central medical imaging management and endoscopic reading - Precision medicine and biomarker solutions - Real-world evidence and clinical consulting - Histopathology and lab services through AcelaBio How to Apply To apply for this position, please submit your resume through the Alimentiv Careers Portal or via LinkedIn’s Easy Apply. Resumes must be submitted in English. ## Equal Opportunity and Accessibility Alimentiv is committed to building a diverse, inclusive and respectful workplace. We are an equal opportunity employer and consider all qualified applicants for employment without regard to race, colour, ethnicity, national origin, religion or belief, sex, gender identity or expression, sexual orientation, age, marital or family status, disability, or any other characteristic protected by applicable law. Accommodations are available upon request for persons with disabilities throughout the recruitment and selection process. Requests can be directed to recruitment@alimentiv.com. Stay Alert to Recruitment Scams Alimentiv is aware of a continued increase in phishing scams, which use various methods of attack via email, text, voice and social media, including individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from company email addresses containing "@alimentiv.com". If you are contacted about an open job at Alimentiv, please verify the domain of the sender's email address and confirm that you are being asked to apply on this website. If something doesn't feel right, we encourage you to verify before responding. If you believe you have been the victim of a phishing scam, please contact your local government cyber authority to report it. ## About Alimentiv ## Company Overview - **One-liner**: Alimentiv is a global, specialized gastrointestinal (GI) contract research organization (CRO) that provides full‑service clinical trials, advanced medical imaging, and precision medicine solutions to accelerate the development of GI therapies. - **Entity Type**: Private (owned by Alimentiv Health Trust, a profit‑with‑purpose trust) - **Headquarters**: London, Ontario, Canada - **Founded**: 1986 (originally as part of Robarts Research Institute; rebranded to Alimentiv in 2020) - **Founders**: Not publicly available (the organization evolved from academic GI research at Robarts Research Institute) ## Core Business - **Primary industry**: Pharmaceutical contract research (CRO), specifically gastrointestinal diseases - **Target customers**: B2B – pharmaceutical and biotechnology companies developing therapies for GI indications (e.g., IBD, celiac disease, eosinophilic esophagitis) - **Mission/purpose**: To advance the science of gastrointestinal diseases by designing and executing better, more efficient trials, generating quality data that bring pivotal GI products closer to patients [alimentiv.com](https://alimentiv.com/about-us/) ## Products & Services Alimentiv offers a comprehensive, end‑to‑end suite of GI‑focused clinical development services: - **Clinical Trial Services**: Full‑service study management, site selection (5,000+ sites in 60+ countries), medical monitoring, and clinical operations. - **Medical Imaging Solutions**: Proprietary platforms including Notō and Lucidity™, central reading for endoscopy, MRE/MRI, intestinal ultrasound (IUS), and AI‑powered tools (DovaVision™ UC, PathwaysGI, IAG). - **Precision Medicine / Biomarkers**: Biomarker analysis, spatial biology, and real‑world evidence services. - **Histopathology & Laboratory Services**: Delivered via AcelaBio, a wholly owned specialty lab offering histopathology and precision medicine for clinical trials. - **Statistics & Data Sciences**: Biostatistics, clinical data management, and medical writing. - **Clinical Pharmacology**: Pharmacokinetic/pharmacodynamic support. ## Market Standing - **Valuation**: Not disclosed (privately held by Alimentiv Health Trust) - **Key Metric**: Annual revenue of $75 M (estimated, per LinkedIn) [linkedin.com](https://linkedin.com/company/alimentiv) - **Notable Investors/Partners**: Alimentiv Health Trust (parent); partnerships with academic centers, imaging societies (IBUS), patient advocacy groups (Crohn’s & Colitis Foundation, Beyond Celiac, EUREOS), and industry consortia (STAR, CDISC Platinum Member). - **Growth Signals**: - Headcount of 507 employees (+13.9% YoY, +81 people) [linkedin.com](https://linkedin.com/company/alimentiv) - Trusted for over 70% of IBD compounds in development globally - Recent expansion into Australia and Latin America (2024) - AI imaging partnerships and new modalities (MRE/MRI, IUS) launched in 2022‑2023 ## Competitive Advantages - **Deep GI specialization**: 30+ years of exclusive focus on gastrointestinal diseases, with deep scientific and operational expertise. - **Proprietary imaging technology**: Advanced central reading platforms (Notō, Lucidity™) and AI‑driven tools that are widely adopted in GI trials. - **Global site network**: 5,000+ GI‑experienced sites across 60+ countries, enabling seamless multi‑regional studies. - **Profit‑with‑purpose ownership model**: Alimentiv Health Trust reinvests profits into research, technology, and employee benefits, creating a long‑term, mission‑driven structure. - **End‑to‑end capabilities**: From clinical management to imaging, biomarkers, histopathology, and statistics – all under one roof. ## Strategic Focus - **Innovation in GI trial design**: Developing validated endpoints, novel imaging biomarkers, and AI‑powered diagnostics. - **Expansion of precision medicine**: Growing histopathology and biomarker services (AcelaBio) and spatial biology offerings. - **Geographic expansion**: Building presence in Asia‑Pacific, Latin America, and Europe to support global trials. - **Partnership development**: Deepening collaborations with academic consortia, patient advocacy groups, and technology partners. ## Why Work Here - **Culture**: Described as “profit‑with‑purpose” – commercial success is channeled back into scientific research, technology, and employees. Employees can become beneficiaries of the Alimentiv Health Trust. - **Work environment**: Flexible and remote work options available for many roles; policies include flexible summer hours, a December holiday shutdown, and “working while visiting” programs. - **Compensation & benefits**: Industry‑benchmarked salaries, performance‑based incentives, retirement/savings plans, comprehensive health/dental/vision, generous paid time off, and parental leave. - **Engineering & science culture**: Focus on “clinical trial excellence” with opportunities to work on the most important GI studies globally. Teams include data sciences, clinical operations, imaging, and biostatistics. - **Social & inclusion**: Employee‑led social committee, virtual and in‑person regional events, and a collaborative, inclusive atmosphere. ## Sources 1. [alimentiv.com – About Us](https://alimentiv.com/about-us/) 2. [alimentiv.com – Careers](https://alimentiv.com/careers/) 3. [linkedin.com – Alimentiv Company Page](https://linkedin.com/company/alimentiv) 4. [alimentiv.com – Global Reach](https://www.alimentiv.com/about-us/global-reach/) 5. 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