[All remote jobs](https://jobicy.com/jobs.md)[![Alimentiv logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2025/06/d11f5845-221.png)](https://jobicy.com/company/alimentiv.md)[Alimentiv](https://jobicy.com/company/alimentiv.md) # TMF Associate AI Summary The TMF Associate manages Trial Master File content and controlled electronic repositories across the clinical-study lifecycle. The role ensures documentation is complete, contemporaneous, organized, and inspection-ready, while supporting periodic reviews, audits, and issue resolution. It partners with cross-functional study teams, provides TMF training, handles help-desk triage, and maintains study-specific filing and oversight materials. Candidates need knowledge of TMF processes, ALCOA principles, relevant clinical-trial regulations, strong organization, and at least three years of related experience.[Apply for this job](#job-application)[View company](https://jobicy.com/company/alimentiv.md)ShareRemote from[UK](https://jobicy.com/job-region/uk.md), [Canada](https://jobicy.com/job-region/canada.md), [Brazil](https://jobicy.com/job-region/brazil.md)+3 more, [Romania](https://jobicy.com/job-region/romania.md), [Poland](https://jobicy.com/job-region/poland.md), [Hungary](https://jobicy.com/job-region/hungary.md)SalaryUndisclosedDepartment[Healthcare & Medical](https://jobicy.com/categories/healthcare.md)EmploymentFull TimeExperienceSeniorPublished7 Nov 2026Apply before7 Dec 2026Listing views49Application actions2Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. Opportunity details ## About this role. 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. ### 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](https://jobicy.com/company/alimentiv.md) ### 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. ### Compensation ### Additional Information Show more [Apply now >](https://jobicy.com/jobs/159476-tmf-associate-2.md) > Annual salary information is not provided for this position. Explore salary ranges for similar roles in our [Salary Directory ›](https://jobicy.com/salaries.md) * ![Upload CV](data:image/svg+xml;base64,PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSI2NSIgaGVpZ2h0PSI2NSIgZmlsbD0ibm9uZSIgeG1sbnM6dj0iaHR0cHM6Ly92ZWN0YS5pby9uYW5vIj48ZyBjbGlwLXBhdGg9InVybCgjQSkiPjxwYXRoIGQ9Ik0wIDBINjVWNjVIMFYwWiIgZmlsbD0iIzAyOWFlYiIvPjxnIGZpbGw9IiNmZmYiIHN0cm9rZT0iI2ZmZiIgc3Ryb2tlLXdpZHRoPSIyIj48cGF0aCBkPSJNMzMuMDQ5IDE1LjQ1NGExLjQzIDEuNDMgMCAwIDAtMi4wOTcgMGwtNy41NzkgOC4xNDdhMS4zOCAxLjM4IDAgMCAwIC4wOSAxLjk3MyAxLjQ0IDEuNDQgMCAwIDAgMi4wMDgtLjA4OGw1LjEwOS01LjQ5MnYyMC42MWExLjQxIDEuNDEgMCAwIDAgMS40MjEgMS4zOTdjLjc4NSAwIDEuNDIxLS42MjUgMS40MjEtMS4zOTd2LTIwLjYxbDUuMTA5IDUuNDkyYTEuNDQgMS40NCAwIDAgMCAyLjAwOC4wODggMS4zOCAxLjM4IDAgMCAwIC4wOS0xLjk3M2wtNy41NzktOC4xNDZ6TTE2Ljc2OSAzOC40YzAtLjc3My0uNjItMS40LTEuMzg1LTEuNFMxNCAzNy42MjcgMTQgMzguNHYuMTAybC4yMTUgNi4yMjljLjIyMyAxLjY4LjcwMSAzLjA5NSAxLjgxMyA0LjIxOHMyLjUxIDEuNjA3IDQuMTcyIDEuODMzYzEuNi4yMTggMy42MzYuMjE4IDYuMTYuMjE4aDExLjI4bDYuMTYtLjIxOGMxLjY2Mi0uMjI2IDMuMDYxLS43MDkgNC4xNzItMS44MzNzMS41ODktMi41MzggMS44MTMtNC4yMThDNTAgNDMuMTEzIDUwIDQxLjA1NSA1MCAzOC41MDNWMzguNGMwLS43NzMtLjYyLTEuNC0xLjM4NS0xLjRzLTEuMzg1LjYyNy0xLjM4NSAxLjRsLS4xOSA1Ljk1OGMtLjE4MiAxLjM3LS41MTUgMi4wOTUtMS4wMjYgMi42MTJzLTEuMjI4Ljg1My0yLjU4MyAxLjAzOGMtMS4zOTUuMTktMy4yNDMuMTkzLTUuODkzLjE5M0gyNi40NjJjLTIuNjUgMC00LjQ5OC0uMDAzLTUuODkzLS4xOTMtMS4zNTUtLjE4NC0yLjA3Mi0uNTIxLTIuNTgzLTEuMDM4cy0uODQ0LTEuMjQyLTEuMDI2LTIuNjEyYy0uMTg3LTEuNDEtLjE5MS0zLjI3OS0uMTkxLTUuOTU4eiIvPjwvZz48L2c+PGRlZnM+PGNsaXBQYXRoIGlkPSJBIj48cGF0aCBmaWxsPSIjZmZmIiBkPSJNMCAwaDY1djY1SDB6Ii8+PC9jbGlwUGF0aD48L2RlZnM+PC9zdmc+) ### Upload your resume now To unlock remote work opportunities and be discovered by global employers. This job listing has been manually reviewed by the Jobicy Trust & Safety Team for compliance with our posting guidelines, including verification of the company's legitimacy, accuracy of job details, clarity of remote work policy, and absence of misleading or fraudulent content. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 4/5EasyHard ### Pace & Pressure 4/5RelaxedFast-paced ### Autonomy Level 4/5GuidedFull ownership ### Communication Load 4/5IndependentCollaborative AI insightРабота требует уверенного знания процессов TMF, принципов целостности данных и требований к готовности к инспекциям. Необходимо самостоятельно расставлять приоритеты по документам, проверкам, тикетам и эскалациям, не теряя точности. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Market rate$65,000US market range (per year)$55k–$78k0$85.80k AI insightThe yearly pay period is inferred from the job context; it was not explicitly stated by the employer. Работодатель не раскрыл базовую оплату. Указана ориентировочная оценка годового дохода для специалиста по TMF/clinical trial documentation на рынке США: медиана около $65,000 USD в год, ориентировочный рыночный диапазон $55,000–$78,000 USD в год. ## Core skills Skills and capabilities most closely associated with this opportunity. [Trial Master File management](https://jobicy.com/jobs?search_keywords=Trial%20Master%20File%20management.md)[Clinical trial documentation](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20documentation.md)[TMF reconciliation](https://jobicy.com/jobs?search_keywords=TMF%20reconciliation.md)[ALCOA principles](https://jobicy.com/jobs?search_keywords=ALCOA%20principles.md)[Electronic document management systems](https://jobicy.com/jobs?search_keywords=Electronic%20document%20management%20systems.md)[GCP compliance](https://jobicy.com/jobs?search_keywords=GCP%20compliance.md)[Clinical study operations](https://jobicy.com/jobs?search_keywords=Clinical%20study%20operations.md)[Quality control](https://jobicy.com/jobs?search_keywords=Quality%20control.md)[Audit readiness](https://jobicy.com/jobs?search_keywords=Audit%20readiness.md)[Document archival](https://jobicy.com/jobs?search_keywords=Document%20archival.md)[Stakeholder management](https://jobicy.com/jobs?search_keywords=Stakeholder%20management.md)[Microsoft Office](https://jobicy.com/jobs?search_keywords=Microsoft%20Office.md)[Help desk triage](https://jobicy.com/jobs?search_keywords=Help%20desk%20triage.md) Sample interview questionsHow do you ensure a Trial Master File remains inspection-ready throughout a study?I establish the expected-document list and filing plan early, monitor document completeness against study milestones, and perform scheduled quality checks. I promptly communicate gaps to document owners, track remediation, and confirm that final records are filed contemporaneously with appropriate metadata. Describe how you would handle an incomplete or out-of-scope document found during a TMF review. I would first verify the document against the TMF reference model, study-specific plan, and expected-document list. I would then notify the responsible study stakeholder with a clear explanation of the issue, track the follow-up action, and escalate through the defined process if the item remains unresolved or creates an inspection risk. What does ALCOA mean in the context of TMF oversight? ALCOA means records should be attributable, legible, contemporaneous, original, and accurate. In TMF oversight, I apply these principles by checking document provenance, readability, timely filing, version control, and accuracy of metadata and content. How would you prioritize TMF help-desk tickets while supporting multiple studies? I would assess each ticket based on inspection risk, study milestone impact, regulatory urgency, and required turnaround time. Critical access issues, filing gaps affecting key milestones, and audit-related requests would receive immediate attention, while all requests would be documented and communicated transparently to stakeholders. How do you train study teams on TMF filing requirements? I tailor training to the study workflow and stakeholder responsibilities, covering the file structure, expected documents, naming and metadata standards, filing timelines, and escalation routes. I use practical examples and follow up with reference materials and targeted refresher sessions when recurring issues are identified. Next step ## Apply now. Follow the employer’s application method and review Jobicy’s safety guidance before sharing personal information. 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