27 set - Bardi
Alira Health
As Project Manager at Alira Health, you will drive the efficient execution of study protocols within scope, budget, and regulatory guidelines. You will partner with the Clinical team, sponsors, and vendors to keep trials on track and deliver timely status updates. You’ll lead cross-functional study activities, oversee TMF processes, and support audits and inspections. This role offers impact across global projects in a values-driven environment that promotes courageous, accountable, honest, inclusive collaboration. You will help shape how we scale high-quality clinical research and sponsor partnerships.Manage clinical studies to meet scope, budget, ICH GCP, FDA regulations, and timelinesServe as study lead and primary sponsor contactOversee clinical study functions (investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, central lab)Generate and present study status updates to sponsorsSupervise and train Clinical team members and Associate PMsCreate and review study documents (protocols, ICF templates, budgets,
site forms)Drive cross-functional teamwork to achieve trial milestonesEnsure accuracy of reports and materialsProvide monthly billing information to financePresent at investigator and client meetingsIdentify issues and implement problem-solving to protect timelinesManage subject accrual, retention, and complianceAssist in TMF management and reviewsPrepare for third-party audits and FDA inspectionsEnsure compliance with ICH GCP, FDA regulations, and SOPsParticipate in meetings as requiredPerform additional duties as assignedBS/BA in life sciences or related discipline; equivalent experience3 years xysqume of pharmaceutical/biotech/CRO experience with at least 1 year in managementstrong organizational and multitasking abilitiesexcellent English communication skills (written and verbal)ability to work in a collaborative, fast-paced environmentproblem-solving and negotiation skillsexperience with cross-functional teams and leadership responsibilitiesdetail-orientedhigh organizational abilitystrong analytical and negotiation skillsMS Office Suite (Word, Excel)IWRS/IXRSdata management#J-18808-Ljbffr
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IT.COR
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