[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 Review the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move. [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 TimeExperienceSeniorPublished25 Oct 2026Apply before24 Nov 2026Listing views41Application actions2Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. AI Summary ## The role, at a glance. The TMF Associate manages Trial Master File documentation throughout the clinical study lifecycle, from setup through transfer and archival. The role maintains inspection-ready electronic records, reconciles expected documents, performs quality checks, and resolves TMF-related issues with study teams. It also includes stakeholder training, help-desk triage, process documentation, and support for departmental quality systems. Candidates need 1–3 years of relevant experience, knowledge of TMF regulations and ALCOA principles, and strong organizational skills. This is a home-based position with potential occasional office attendance. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 3/5EasyHard ### Pace & Pressure 4/5RelaxedFast-paced ### Autonomy Level 3/5GuidedFull ownership ### Communication Load 4/5IndependentCollaborative AI insightThe work requires careful knowledge of clinical-trial documentation, data integrity, and inspection-readiness standards. It is moderately demanding because accuracy, timeliness, and coordination across several study stakeholders are essential. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Market rate$62,000US market range (per year)$50k–$75k0$82.50k AI insightThe yearly pay period is inferred from the job context; it was not explicitly stated by the employer. No employer compensation was disclosed. The annual figures are AI-estimated USD market compensation for a TMF Associate in the US market; the yearly cadence is inferred from the permanent full-time professional role. ## 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 quality control](https://jobicy.com/jobs?search_keywords=TMF%20quality%20control.md)[ALCOA principles](https://jobicy.com/jobs?search_keywords=ALCOA%20principles.md)[Electronic document management](https://jobicy.com/jobs?search_keywords=Electronic%20document%20management.md)[Document reconciliation](https://jobicy.com/jobs?search_keywords=Document%20reconciliation.md)[Inspection readiness](https://jobicy.com/jobs?search_keywords=Inspection%20readiness.md)[Clinical research regulations](https://jobicy.com/jobs?search_keywords=Clinical%20research%20regulations.md)[Study lifecycle management](https://jobicy.com/jobs?search_keywords=Study%20lifecycle%20management.md)[Stakeholder training](https://jobicy.com/jobs?search_keywords=Stakeholder%20training.md)[Records archiving](https://jobicy.com/jobs?search_keywords=Records%20archiving.md)[Microsoft Office](https://jobicy.com/jobs?search_keywords=Microsoft%20Office.md)[Time management](https://jobicy.com/jobs?search_keywords=Time%20management.md)[Problem solving](https://jobicy.com/jobs?search_keywords=Problem%20solving.md) Sample interview questionsHow do you ensure that a Trial Master File remains inspection-ready throughout a study?I use the study file index and expected document lists to perform routine completeness reviews, confirm documents are filed contemporaneously, and follow up promptly on missing or incomplete records. I document findings, escalate risks when needed, and maintain a clear audit trail for all actions. What does ALCOA mean in the context of TMF oversight? ALCOA refers to records being attributable, legible, contemporaneous, original, and accurate. In TMF oversight, I apply these principles by checking that documents have appropriate authorship, dates, version control, readability, source integrity, and accurate metadata. How would you manage an incomplete document identified during a periodic TMF review? I would verify the expected document and applicable milestone, identify the responsible study-team contact, and communicate the gap with a clear request and due date. I would track the issue to resolution and escalate according to the TMF management plan if the item could affect inspection readiness. Describe your approach to prioritizing TMF help-desk tickets and competing study requests. I assess requests by study risk, inspection or milestone impact, urgency, and the potential effect on document accessibility. I acknowledge requests promptly, resolve straightforward issues efficiently, communicate expected timelines, and escalate complex access or quality concerns to the appropriate lead. How would you train a new stakeholder on study-specific TMF requirements? I would tailor training to the stakeholder's responsibilities and explain the file structure, expected documents, filing timelines, naming conventions, and quality expectations. I would use practical examples, provide written work instructions, and confirm understanding through questions or a short walkthrough. 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. 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 1-3 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](mailto: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. ### Compensation ### Additional Information Show more [Apply now >](https://jobicy.com/jobs/156938-tmf-associate.md) > Annual salary information is not provided for this position. 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