{"id":1189141,"url":"https://alion.io/job/excelya-etmf-functional-systems-specialist","title":"eTMF Specialist","company":{"id":4705,"name":"Excelya","domain":"excelya.com","url":"https://alion.io/company/excelya","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":null},"role":"Management","role_family":"Management","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":81000,"max_usd":188000,"period":"year","method":"role_country_seniority_unknown","sample_n":10060},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"closed","first_seen_at":"2026-09-24T15:26:04Z","employer_posted_date":"2026-09-24","last_verified_at":"2026-10-13T09:30:41Z","board_verified":false,"closed_at":"2026-10-13T09:30:41Z","days_open":18,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":18},"description":"Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.\nThe successful candidate will work closely with Clinical Project Managers, Clinical Trial Associates, Clinical Operations teams, and CRO partners to ensure TMFs remain complete, compliant, and inspection-ready throughout the study lifecycle.\nKey Responsibilities:\nManage and maintain TMF/eTMF documentation throughout the entire clinical trial lifecycle, from start-up to archiving.\nEnsure TMF completeness, quality, accuracy, and inspection readiness at all times.\nConduct TMF quality reviews, reconciliation activities, and completeness assessments.\nTrack, follow up, and resolve missing, incomplete, or overdue study documents.\nMonitor and report TMF health, quality, and compliance metrics.\nCollaborate closely with Clinical Project Managers, Clinical Operations teams, CTAs, and CRO partners.\nProvide guidance on TMF requirements, filing standards, documentation practices, and compliance expectations.\nManage daily activities within Veeva Vault eTMF, including document filing, classification, and metadata management.\nServe as a Subject Matter Expert (SME) for eTMF processes and Veeva Vault, while supporting process improvements and system enhancements.\nEnsure compliance with ICH-GCP, regulatory requirements, and SOPs, support audits and inspections, contribute to remediation plans, and deliver TMF-related training and best practices to study teams and CROs.\nRequirements\nBachelor’s degree in Life Sciences or a related scientific discipline.\nMinimum 5 years of experience in TMF/eTMF management within clinical research.\nProven hands-on expertise with Veeva Vault eTMF.\nStrong understanding of Clinical Operations and end-to-end clinical trial processes.\nExperience supporting inspection readiness, audits, and regulatory inspections.\nSolid knowledge of ICH-GCP guidelines and the TMF Reference Model.\nExperience collaborating with CROs and cross-functional clinical study teams.\nStrong communication, stakeholder management, and organizational skills.\nBenefits\nWhy Join Us?\nAt Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.\nHere’s what makes us unique.\nWe are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.\nExcelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.","description_format":"text","description_chars":2996,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-09-24T15:26:04Z"},{"event":"close","at":"2026-10-13T09:30:41Z"}],"visa":[],"liveness":null,"pay":null,"html_url":"https://alion.io/job/excelya-etmf-functional-systems-specialist","json_url":"https://alion.io/job/excelya-etmf-functional-systems-specialist.json","meta":{"generated_at":"2026-10-13T19:44:36Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":30279,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4705},"rest":"https://alion.io/mcp/rest/get_company?id=4705"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fexcelya-etmf-functional-systems-specialist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fexcelya-etmf-functional-systems-specialist"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fexcelya-etmf-functional-systems-specialist"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/excelya-etmf-functional-systems-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fexcelya-etmf-functional-systems-specialist"}]}