--- title: 'TMF Coordinator at Alimentiv' canonical: 'https://feeny.ai/job/tmf-coordinator-alimentiv-warsaw-bj42h6xntqad' type: 'job' last_seen: '2026-09-13' --- # TMF Coordinator at Alimentiv - **Company:** Alimentiv - **Location:** Warsaw, Poland - **Compensation:** $42k–$70k - **Employment:** full-time - **Work type:** remote - **Posted:** 2026-09-10 - **Last confirmed live:** 2026-09-13 - **Apply:** https://jobs.lever.co/alimentiv-2/37f5a089-5f5e-4e0d-ba52-5f0be2911b3e ## Job description We are seeking a detail-oriented and highly organized TMF Coordinator to join our TMF Operations team. In this role, you will be responsible for maintaining the quality, completeness, and compliance of Trial Master File (TMF) documentation in alignment with global regulatory requirements and company standards.  You will play a key role in ensuring that TMF content remains inspection-ready and supports clinical trial execution through effective document management and collaboration with cross-functional stakeholders. Positions Available: 2; Note this position is cross-listed in multiple countries. TMF Oversight & Compliance - Maintain in-depth knowledge of TMF structures (paper and electronic) - Ensure compliance with ICH-GCP, FDA, and EMA regulations - Apply ALCOA+ data integrity principles - Support inspection readiness and audit activities - Ensure proper management of essential clinical trial documentation Systems & Document Management - Accurately file, classify, and index documents within the TMF - Ensure adherence to version control and naming conventions - Utilize eTMF systems (e.g., Veeva Vault, Phlexglobal, Trial Interactive) - Maintain consistency and compliance of TMF structure - Demonstrate proficiency in eTMF and document management systems - Utilize Microsoft Office tools (Excel, Word, SharePoint) for reporting and coordination Quality Control - Perform QC checks on TMF documents and metadata - Identify and resolve missing, incomplete, or inconsistent records - Ensure overall accuracy, completeness, and timeliness of TMF content - Support TMF health checks and reporting metrics Issue Resolution & Continuous Improvement - Investigate and resolve TMF gaps and discrepancies - Troubleshoot filing and system-related issues - Contribute to process improvements and standardization initiatives - Support root cause analysis for quality issues Stakeholder Engagement - Collaborate with study teams and Proactively follow up on outstanding documentation - Provide clear guidance on TMF requirements and processes - Support audit and inspection readiness activities Required Qualifications & Experience - Bachelor’s degree in Life Sciences or a related field (preferred) - 1-3 years experience in clinical trials TMF management - Working knowledge of eTMF platforms and regulatory requirements - Strong understanding of clinical trial record management and quality standards - Working remotely Core Competencies - Strong attention to detail and quality focus - Excellent organizational and time management skills - Effective communication and stakeholder engagement - Analytical thinking and problem-solving ability - Ability to manage multiple priorities in a fast-paced environment ## 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) ## Other roles at Alimentiv - [TMF Coordinator](https://feeny.ai/job/tmf-coordinator-alimentiv-london-dy3evtr4zgy8) — London, United Kingdom - [Join our Talent Pool - Sr Clinical Research Associate (Croatia)](https://feeny.ai/job/join-our-talent-pool-sr-clinical-research-associate-croatia-alimentiv-zagreb-0d8qrwbdyjzd) — Zagreb, Croatia - [Join our Talent Pool - Sr Clinical Research Associate (Serbia)](https://feeny.ai/job/join-our-talent-pool-sr-clinical-research-associate-serbia-alimentiv-belgrade-kjenabgdz27h) — Belgrade, Serbia - [Sr Clinical Research Associate (South Africa)](https://feeny.ai/job/sr-clinical-research-associate-south-africa-alimentiv-johannesburg-g50zhwdewkr9) — Johannesburg, South Africa - [Imaging Clinical Project Manager (1 -Year Limited Term)](https://feeny.ai/job/imaging-clinical-project-manager-1-year-limited-term-alimentiv-london-6rhrkbc9xfkg) — London, United Kingdom - [Join our Talent Pool - Sr Clinical Research Associate (Portugal)](https://feeny.ai/job/join-our-talent-pool-sr-clinical-research-associate-portugal-alimentiv-lisboa-46mx78pmjtpn) — Lisboa, Portugal - [Senior Proposal Specialist](https://feeny.ai/job/senior-proposal-specialist-alimentiv-london-fd452a49yrnk) — London, United Kingdom - [Medical Writer](https://feeny.ai/job/medical-writer-alimentiv-toronto-wvyyv7yewj6q) — Toronto, Canada - [ERP System Administrator (Acumatica)](https://feeny.ai/job/erp-system-administrator-acumatica-alimentiv-adelaide-4742ccm08bzn) — Adelaide, Australia - [ERP System Administrator (Acumatica)](https://feeny.ai/job/erp-system-administrator-acumatica-alimentiv-toronto-wwbz8kze7b6x) — Toronto, Canada