Clinical Trial Manager

1 giorno fa

Varese VA, Provincia di Varese; Lombardia, Italia Alira Health Tempo pieno
Overview As Project Manager at Alira Health, you will drive the efficient execution of study protocols within scope, budget, and regulatory guidelines. 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 timelines Serve as study lead and primary sponsor contact Oversee clinical study functions (investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, central lab) Supervise and train Clinical team members and Associate PMs Ensure accuracy of reports and materials Provide monthly billing information to finance Maintain frequent management updates Assist in TMF management and reviews Prepare for third-party audits and FDA inspections Ensure compliance with ICH GCP, FDA regulations, and SOPs BS/BA in life sciences or related discipline; equivalent experience ~3 years of pharmaceutical/biotech/CRO experience with at least 1 year in management ~ excellent English communication skills (written and verbal) ~ MS Office proficiency (Word, Excel) ~ problem-solving and negotiation skills ~ experience with cross-functional teams and leadership responsibilities ~ strong analytical and negotiation skills ~ MS Office Suite (Word, Excel) ~ data management