Clinical Study Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7xlrw0

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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7xlrw0