Senior Clinical Project Lead – Global Trials & Sponsors

Alira Health Boston, LLC; Boston (MA); Hybride; USD 140 000 - 150 000; Plein temps

Résumé du poste

Alira Health Boston, LLC is seeking a Sr. Project Manager to join our Clinical team. The SCPM will oversee the efficient execution of study protocols, coordinate with sponsors and vendors, and ensure adherence to ICH GCP and FDA regulations.

You will lead cross-functional study activities, manage timelines, budgets, TMF, and participate in audits. The role requires a BS/BA in life sciences and at least 5 years of clinical project management within pharma/biotech/CRO.

Qualifications

• BS/BA in life sciences or related discipline.
• 10 years of experience in the pharmaceutical/biotechnology/CRO industry with at least 5 years of clinical project management experience.
• Strong organizational, analytical, negotiation, meeting management, cross-functional team, and leadership skills.

Responsabilités

• Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines.
• Serves as study lead and primary contact for sponsors.
• Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory.
• Generates and presents frequent study status updates and reports to sponsor.
• Supervises and trains Associate CPMs and provides ongoing support and high-level guidance to CPMs.

Connaissances

Attention to detail

Organizational skills

Analytical skills

Leadership

Communication

Problem solving

English proficiency

Cross-functional collaboration

Formation

BS/BA in Life Sciences or related discipline

Outils

MS Office

Description du poste

Alira Health Boston, LLC is seeking a Sr. Project Manager to join our Clinical team. The SCPM will oversee the efficient execution of study protocols, coordinate with sponsors and vendors, and ensure adherence to ICH GCP and FDA regulations.

You will lead cross-functional study activities, manage timelines, budgets, TMF, and participate in audits. The role requires a BS/BA in life sciences and at least 5 years of clinical project management within pharma/biotech/CRO.