16 ott - Bardi
Alira Health
OverviewAs 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.
ResponsabilitàManage clinical studies to meet scope, budget, ICH GCP, FDA regulations, and timelines
Serve as study lead and primary sponsor contact
Oversee clinical study functions (investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, central lab)
Generate and present study status updates to sponsors
Supervise and train Clinical team members and Associate PMs
Create and review study documents (protocols, ICF templates, budgets, site forms)
Drive cross-functional teamwork to achieve trial milestones
Ensure accuracy of reports and materials
Provide monthly billing information to finance
Present at investigator and client meetings
Maintain frequent management updates
Identify issues and implement problem-solving to protect timelines
Manage subject accrual, retention, and compliance
Assist in TMF management and reviews
Prepare for third-party audits and FDA inspections
Ensure compliance with ICH GCP, FDA regulations, and SOPs
Participate in meetings as required
Perform additional duties as assigned
Requisiti fondamentaliBS/BA in life sciences or related discipline; equivalent experience
3 years of pharmaceutical/biotech/CRO experience with at least 1 year in management
strong organizational and multitasking abilities
excellent English communication skills (written and verbal)
MS Office proficiency (Word, Excel)
ability to work in a collaborative, fast-paced environment
problem-solving and negotiation skills
experience with cross-functional teams and leadership responsibilities
detail-oriented
high organizational ability
strong analytical and negotiation skills
MS Office Suite (Word, Excel)
IWRS/IXRS
data management
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