Project Manager – Clinical Research

About the role

The Project Manager will be a core member of Alira Health's Clinical team, overseeing the efficient implementation of one or more study protocols. This role involves close collaboration with internal clinical staff, sponsors, and external vendors to ensure study success across multiple time zones.

Key responsibilities

• Manage clinical research studies in line with scope, budget, ICH GCP, FDA regulations and timelines.
• Serve as primary contact for sponsors and lead study communications.
• Oversee study functions such as investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance and central laboratory.
• Generate and present regular status updates and reports to sponsors.
• Supervise Clinical Assistants, In‑house and external Clinical Research Associates, and train Associate Project Managers.
• Create and review study documents including protocols, ICF templates, budgets, site manuals and TMF materials.
• Drive teamwork, ensure milestone attainment, and manage subject accrual, retention and compliance.
• Prepare for and participate in audits, FDA inspections and third‑party reviews.

Required profile

• Bachelor’s degree in life sciences or related field, or equivalent experience.
• Minimum 3 years of experience in pharmaceutical, biotechnology or CRO environments, with at least 1 year of management experience.
• Strong organizational, analytical and detail‑oriented abilities.
• Ability to multitask in a fast‑paced environment and communicate effectively with diverse stakeholders.

Required skills

• Knowledge of ICH GCP guidelines.
• Familiarity with FDA regulations.
• Experience with IWRS/IXRS systems.
• Data management proficiency.
• Understanding of biostatistics.
• Pharmacovigilance processes.
• Trial Master File (TMF) management.