Overview

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.

Responsabilità

- Manage 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 fondamentali

- BS/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

Clinical Trial Liaison Manager

Impiegato/a full time Teleselling

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