---
title: 'Clinical Operations Lead (Clinical Trial Manager) at Alimentiv'
canonical: 'https://feeny.ai/job/clinical-operations-lead-clinical-trial-manager-alimentiv-budapest-2ykmmfdbzy53'
type: 'job'
last_seen: '2026-09-13'
---

# Clinical Operations Lead (Clinical Trial Manager) at Alimentiv

- **Company:** Alimentiv
- **Location:** Budapest, Hungary
- **Employment:** full-time
- **Work type:** remote
- **Posted:** 2024-12-23
- **Last confirmed live:** 2026-09-13
- **Apply:** https://jobs.lever.co/alimentiv-2/3e3693cf-bcf6-4ca8-a28d-4272137282b5

## Job description

Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.

Project Oversight

- Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.
- Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.
- May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)
- Oversee regional startup and feasibility activities.
- Assist in vendor management activities as required per project.
- Perform review of visit reports for quality, compliance and appropriate site management.
- Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
- Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.
- Contribute to financial project management processes as applicable.  May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.
- May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.

Project Liaison

- Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
- Attend meetings with Study Sponsor to provide status updates on country and site progress
- Provide operational support and guidance to the monitoring team throughout project.
- Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.
- First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.
- Support line managers by providing status updates on utilization and performance of CRAs.
- Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.
- Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.

Study Documents and Plans

- Develop training materials and study tools for sites and CRAs, including monitoring plans.
- Develop and implement enrolment and recruitment strategies together with clinical project team.
- Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.

## Qualifications

- College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading

OR

- Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training

Other

- Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
- Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.
- Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.
- Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.
- Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.

Working Conditions

- Home-based

Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com

PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.

## 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. [jobs.lever.co – Alimentiv Open Roles](https://jobs.lever.co/alimentiv-2)

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