{"id":3158911,"url":"https://alion.io/job/psi-regional-project-lead-5","title":"Regional Project Lead","company":{"id":4862,"name":"PSI","domain":"psi-cro.com","url":"https://alion.io/company/psi-cro","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":80,"open_postings":14,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":20,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":122000,"max_usd":223000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":200},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-23T12:31:39Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-10-31T15:39:59Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"We are the company that cares - for our staff, our clients, our partners, and the quality of the work we do.\nFounded in 1995, PSI CRO is a privately owned, global contract research organization with more than 3,000 passionate professionals dedicated to advancing medical science and improving patients' lives.\nIn an industry where change is constant, PSI stands apart. We have remained privately held, have never experienced a merger or acquisition, and have never had company-wide layoffs. Our long-term stability allows us to focus on what matters most - our people, our clients, and delivering exceptional clinical research.\nIf you're looking for a company where you can build a long-term career, grow professionally, and make a meaningful impact, PSI is the right choice for you.\n At PSI CRO, our Regional Project Leads are trusted leaders who drive the successful delivery of clinical trials across multiple countries. You'll partner with Project Managers, CRAs, sponsors, and cross-functional teams to ensure studies are executed efficiently while mentoring project teams and maintaining the highest standards of quality.\nIf you're an experienced Clinical Trial Manager or Regional Lead looking for a collaborative environment where your expertise is valued and your career can continue to grow, we'd love to hear from you.\nJob Duties Include:\nEnsures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents)\nActs as primary or secondary project management contact for the project team and PSI support services in designated countries\nPerforms study status review and progress reporting (if delegated by the Project Manager)\nCollects and reports project status updates for designated regions, both internally and externally\nDevelops and updates project planning documents, essential study documents and project manuals/ instructions\nManages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members\nEnsures that the project timelines and subject enrollment targets are met in designated countries\nCoordinates maintenance of study-specific and corporate tracking systems\nCoordinates site contractual startup and budget negotiations\nEstablishes communication lines within the project team and supervises clinical project team members’ performance\nIdentifies, escalates and resolves resourcing and performance issues\nConducts and supervises therapeutic area training of the project team (if delegated by the Project Manager)\nPrepares presentations and conducts training of Investigators\nEnsures team compliance with project-specific training matrix\nPerforms field training of Monitors tailored to the project needs\nSupervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits\nOversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process\nSupervises project team preparation for study audits/ inspections and resolution of audit/ inspection findings\nCoordinates conduct of supervised monitoring visits\nReviews site visit reports and ensures monitoring and reporting standards are met \nCoordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications\nOversees the safety information flow and participates in feasibility research\nReviews/approves project related expenses and timesheets (if delegated by the Project Manager)\n College/University degree in Life Sciences or an equivalent combination of education, training & experience is required\nPrior experience in Clinical Research and independent on-site monitoring is required\nExperience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is required\nTherapeutic expertise in Oncology and/or Gastroenterology required\nFull working proficiency in English\nProficiency in MS Office applications, including MS Project\nCommunication, presentation and customer-service skills\nAbility to negotiate and build relationships at all levels\nTeam building, leadership and organizational skills\nFor this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.\n Why Join PSI?\nAt PSI, you'll join a privately owned, global CRO with over 30 years of steady growth. Unlike many organizations in our industry, we've remained independent, have never experienced layoffs, and continue to invest in our people.\nHere you'll find:\nOpportunities to lead complex global studies\nA collaborative, people-first culture\nCareer growth and professional development\nFlexible working arrangements\nA stable organization where long-term careers are built\nMeaningful work that helps bring innovative therapies to patients around the world","description_format":"text","description_chars":4975,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Flexible schedule","Professional development"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-23T15:26:56Z"}],"visa":[],"liveness":{"score":57,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":0.9,"age_days":7,"expected_fill_days":20,"reasons":["conf:1","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/psi-regional-project-lead-5","json_url":"https://alion.io/job/psi-regional-project-lead-5.json","meta":{"generated_at":"2026-10-31T16:34:31Z","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":25918,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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":4862},"rest":"https://alion.io/mcp/rest/get_company?id=4862"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpsi-regional-project-lead-5"},{"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%2Fpsi-regional-project-lead-5"},{"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%2Fpsi-regional-project-lead-5"},{"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/psi-regional-project-lead-5\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpsi-regional-project-lead-5"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3158911}},{"tool":"search_jobs","arguments":{"company":"psi-cro.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3158911},"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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