{"id":3546721,"url":"https://alion.io/job/premier-research-tmf-lead-ii","title":"TMF Lead II","company":{"id":2350903,"name":"Premier Research","domain":"premier-research.com","url":"https://alion.io/company/premier-research","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":9,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":18,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Argentina","United States"],"countries":["AR","US"],"hiring_countries":["AR"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":55000,"max_usd":131000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":137},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-10-30T21:04:07Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-04T21:53:08Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Premier Research is looking for a TMF Lead II to join our Pharmacovigilance and Records Management team.You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.\nWe are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.\n\nYour ideas influence the way we work, and your voice matters here.\n\nAs an essential part of our team, you help us deliver the medical innovation that patients are desperate for.\n\nJoin us and build your future here.\nPOSITION SUMMARY:\nPerforms electronic and/or paper Trial Master File records management activities ensuring that TMF records are managed according to Company, Sponsor, Industry, ICH-GCP and global Regulatory standards. Leads the set-up, maintenance and closure of TMFs, including development and ownership of study TMF Plans and indexes. May perform TMF Transitions and use Sponsor TMF processes and systems. Provides oversight, training, KPI analysis and reporting of TMF status to ensure Premier project teams, Sponsors and Third Parties are compliant with prevailing TMF SOPs, TMF Plans and TMF Transition Plans. Takes initiative to identify and address TMF quality and completeness deficiencies that may impact audit and inspection readiness as well as the successful delivery of high-quality TMFs. \nROLE RESPONSIBILITIES:\nActs as primary TMF point of contact for project teams, Sponsors, auditors and other third parties for assigned studies. \nWorks directly with the records specialists assigned to their studies. \nWorks with eTMF Administrator to identify and assist in the resolution of system related issues if/as needed. \nReads and understands the TMF scope of work to be performed on assigned studies. Identifies any out-of-scope activities and reports to department management for change order consideration on assigned studies. \nProvides regular TMF status updates to Project Leadership and Functions on the quality and timeliness of document submissions on assigned studies. \nAssists with monitoring the security, environment and access control of Secure File Room (SFR) facilities (if applicable). \nMonitors compliance to TMF SOPs and TMF Plans for assigned studies. \nPerforms live, web-based and/or recorded TMF process and systems training for Premier project teams, Sponsor and other Third Parties on assigned studies. \nPerforms all departmental budgeted activities for assigned studies. \nDevelops, signs and maintains TMF Plans, TMF Transition Plans and indexes for assigned studies. \nParticipates in TMF audits and inspections as TMF representative for assigned studies. \nCoordinates project team quality reviews of TMFs in accordance with TMF SOPs and TMF Plans for assigned studies. \nREQUIREMENTS:\nMinimum of a high school diploma or international equivalent required. Undergraduate degree preferred from an accredited institution majoring in records and information management, library science, clinical, science or health related field preferred - or - an equivalent level of clinical trials records management experience. \n8+ years eTMF systems experience required. \n8+ years of Trial Master File management experience required. \n8+ years TMF Reference Model experience required. \n2+ years TMF Lead experience required. \nKnowledge of ICH-GCP, ISO14155, FDA CFR Part 11 and Global Regulations related to the investigational drug and device industry required.","description_format":"text","description_chars":3658,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Argentina","iso":"AR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-10-30T21:04:07Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":4,"expected_fill_days":18,"reasons":["conf:4","win:early"],"computed_at":"2026-11-04T06:34:25Z"},"pay":null,"html_url":"https://alion.io/job/premier-research-tmf-lead-ii","json_url":"https://alion.io/job/premier-research-tmf-lead-ii.json","meta":{"generated_at":"2026-11-04T23:56:18Z","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":74,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"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":2350903},"rest":"https://alion.io/mcp/rest/get_company?id=2350903"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpremier-research-tmf-lead-ii"},{"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%2Fpremier-research-tmf-lead-ii"},{"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%2Fpremier-research-tmf-lead-ii"},{"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/premier-research-tmf-lead-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpremier-research-tmf-lead-ii"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3546721}},{"tool":"search_jobs","arguments":{"company":"premier-research.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3546721},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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