{"id":3104579,"url":"https://alion.io/job/iqvia-study-process-lead-sr-study-process-lead","title":"Study Process Lead / Sr. Study Process Lead","company":{"id":4918,"name":"IQVIA","domain":"iqvia.com","url":"https://alion.io/company/iqvia","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":78,"open_postings":517,"ghost_share":0.01,"stale_share":0.826,"repost_share":0.027,"time_to_fill_p50_days":22,"computed_at":"2026-10-24T06:02:35Z"}},"role":"Finance","role_family":"Finance","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mexico City, Mexico"],"countries":["MX"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false},{"name":"SharePoint","optional":false},{"name":"Medidata Rave","optional":true},{"name":"Microsoft Excel","optional":true},{"name":"Veeva","optional":true}],"status":"live","first_seen_at":"2026-10-22T18:36:58Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-25T00:35:42Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Job Overview:\nThe Study Process Lead (SPL) oversees the execution of processes (structured, repeatable sets of deliverables related but not limited to eTMF support, EDC review, CTMS updates, Payment reconciliation, etc.) supporting clinical projects and research studies in accordance with global and local regulations.\nSPLs collaborate closely with operational staff (CPCs/CPAs) and the management team (LMs) and serve as key members of a team of Centralized Administrative Services supporting a single Sponsor.\nManages operational elements of processes supporting clinical projects to deliver contracted clinical services to client satisfaction by having ownership of the process and serving as point of contact (PoC) for client facing activities related to task planning, process updates, and any additional Ad-Hoc requirement.\nAssures that all documentation complies with the expected quality, correct artifact, metadata, and location in accordance with customer internal conventions, SOPs, and WIs.\nOversees, leads and assures the quality in the update of the clinical/regulatory databases such as CTMS, RDMS, and Clinical dashboards as per international guidance, GCPs, customer internal conventions, SOPs and WIs.\nManages and leads scheduled and ad-hoc payments reconciliations in accordance with customer internal conventions, SOPs and WIs.\nManages and leads any additional activity identified within the scope of work of services provided to the client, fostering quality and compliance with GCPs and any applicable guidance, customer internal conventions, SOPs and WIs.\nEssential Functions:\nIncludes but not limited to:\nFully owns the assigned processes from process creation and continuously through process execution and improvement.\nTo act as a leader of the tasks under assigned processes by:\nEnsuring correct scope definition, appropriate resourcing, and effective workforce organization.\nPerforming close oversight of task progress and completion within the defined delivery deadlines.\nProviding CPC/CPA with ongoing support during task completion.\nProviding on demand training and creating relevant guidance materials for task completion.\nOn-time escalation to LM team of performance issues and/or deliveries at risk.\nEffectively communicates with the Client, other SPLs, CPCs/CPAs and the LM team on process performance, escalations, identified issues, process improvement proposals, etc.\nAssists the Client in effective management and oversight of activities including but not limited to:\neTMF management, such as document filing, post-approval QC review, etc.\nRegulatory documentation filing.\nCreation of Safety Letter packages for site activation.\nCompilation of PD Listings and filing in eTMF.\nCreation of CSR Appendices.\nReconciliation of payments at different levels and timeframes.\nAccess management for external users to Client’s SharePoint.\nAny additional activity identified and previously approved by the Client to be within Scope of Work.\nMinimum requirements for Study Process Lead (G130)/Sr. Study Process Lead (G140):\nMinimum 3-4 years of experience (4-5 years for Sr. Study Process Lead) in the clinical trial industry (previous CRO employment).\nExcellent command of English language.\nExcellent command of Microsoft Office.\nWorking knowledge of Project Management principles (In-depth knowledge required for Sr. Study Process Lead) - Planning, Resourcing, Execution, Oversight, Risk Management (any completed Project Management Fundamentals course is a plus).\nAt least 2 years of experience (3 years for Sr. Study Process Lead) with Clinical Trial Management systems (CTMS) and/or eTMF (preferably Veeva Vault eTMF).\nPreferably with previous experience as Senior Clinical Trial Assistant / Project Support Coordinator / Senior eTMF File reviewer, or Project Management Analyst / Project Support Coordinator with minimum 1 year of experience in the role.\nExperience with EDC (Medidata), Regulatory Management systems, and Contract Management systems is a plus.\nExperience as Subject Matter Expert (SME) and/or Trainer and/or Mentor is a plus.\nExperience in client facing role is a plus.\nExperience with advanced Excel features is a plus (Macros, Analytics).\nIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com\nIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.","description_format":"text","description_chars":5071,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)","Health Data & Interoperability"],"lifecycle":[{"event":"open","at":"2026-10-22T18:36:58Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":1,"expected_fill_days":22,"reasons":["conf:3","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/iqvia-study-process-lead-sr-study-process-lead","json_url":"https://alion.io/job/iqvia-study-process-lead-sr-study-process-lead.json","meta":{"generated_at":"2026-10-25T04:43:41Z","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":6282,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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":4918},"rest":"https://alion.io/mcp/rest/get_company?id=4918"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fiqvia-study-process-lead-sr-study-process-lead"},{"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%2Fiqvia-study-process-lead-sr-study-process-lead"},{"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%2Fiqvia-study-process-lead-sr-study-process-lead"},{"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/iqvia-study-process-lead-sr-study-process-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fiqvia-study-process-lead-sr-study-process-lead"}]}