---
title: 'TMF Associate at Alimentiv'
canonical: 'https://feeny.ai/job/tmf-associate-alimentiv-warsaw-zpt1xmgvsnf0'
type: 'job'
last_seen: '2026-11-08'
---

# TMF Associate at Alimentiv

- **Company:** Alimentiv
- **Location:** Warsaw, Poland
- **Employment:** full-time
- **Work type:** remote
- **Posted:** 2026-11-06
- **Last confirmed live:** 2026-11-08
- **Apply:** https://jobs.lever.co/alimentiv-2/eb998ca5-2c9a-4b74-b478-fdae8da15763

## Job description

Job Title: TMF Associate

Employment Type: Full time, Permanent

Job Reports To: Manager, TMF Operations

Department/Unit Name: TMF Operations

Job Summary: Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to the TMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access management framework. Work proactively and successfully within a cross-functional team. Communicate and promote department and company goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude. Time allocated may be adjusted based on need.

Positions Available: 2; Note this position is cross-listed in multiple countries.

Service Delivery

- Serve as the primary TMF contact for assigned studies.
- Ensure TMF is complete and “inspection ready” throughout study lifecycle and documents are filed contemporaneously.
- Work with Team Lead to create study specific TMF management and oversight documents (e.g., File Index, Expected Document Lists and TMF Management Plan) in alignment with study.
- Develop and maintain study-specific work instructions, as needed.
- Utilize organization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completeness.
- Review and communicate out-of-scope and/or incomplete documents to study teams; escalating as needed.
- Reconcile expected document lists based on study events and milestones.
- Prioritize and resolve TMF help desk tickets; may include triaging activities.
- Provide study specific TMF training to internal and/or external stakeholders, as needed.
- Process and review documents, following applicable scanning and best practices and best practices, and applying ALCOA principles appropriately.
- File and retrieve TMF documents in a timely manner.

Department Support

- Complete routine administrative tasks in a timely manner (e.g., timesheets, metrics).
- Participate in discussions, decisions and sharing of knowledge in department meetings, periodic presentations, and smaller working groups.
- Seek opportunities to assist in the development, implementation and maintenance of internal systems (e.g., databases used to manage records).
- Provide mentorship and training to junior level staff.
- Propose suggestions and work on the development and maintenance of department quality system documents to improve efficiencies.

## Qualifications

- The successful candidate will possess a college diploma/degree and 3 years of relative related experience or on going training. They will have an understanding of TMF organization, implementation, and archival including relevant regulations and guidance to assure quality and integrity of TMFs. Have the ability to incorporate the principles of ALCOA in relation to TMF oversight.  Utilize skills in time management and problem-solving.  Identify challenges and problems and take the initiative to identify solutions.  Demonstrated computer literacy, proven functional knowledge of Microsoft packages and potential to develop.

Working Conditions

- - Home based, with the ability to go into office occasionally if needed.
- *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

Warning

- 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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