Remote Senior Clinical Project Lead

Alira Health

Boston (MA)

Hybrid

USD 140,000 - 150,000

Full time

10 days ago

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Job summary

Alira Health is seeking a Senior Project Manager to drive the implementation of study protocols within the Clinical team. You will coordinate with sponsors, vendors, and cross-functional colleagues to ensure milestones are achieved and data is accurate.

You will supervise clinical teams, contribute to TMF reviews, and support audits while ensuring compliance with ICH GCP and FDA regulations. This role supports remote work with Boston-area flexibility.

Qualifications

  • BS/BA in life sciences or related field or equivalent experience.
  • 10 years in pharma/biotech/CRO with 5+ years clinical PM experience.
  • Strong knowledge of ICH GCP and FDA regulations.

Responsibilities

  • Manages clinical studies to ensure scope, budget, timelines, and regulatory requirements are met.
  • Acts as study lead and primary contact for sponsors.
  • Generates study status updates and reports for sponsors.

Skills

Clinical project management
FDA regulations
ICH GCP guidelines
Biostatistics
Data management

Education

Bachelor of Science in Biology/Biotechnology/Life Sciences/Pharmacy

Tools

MS Office Suite (Word, Excel)
IWRS/IXRS
TMF systems

Job description

Alira Health is seeking a Senior Project Manager to drive the implementation of study protocols within the Clinical team. You will coordinate with sponsors, vendors, and cross-functional colleagues to ensure milestones are achieved and data is accurate.

You will supervise clinical teams, contribute to TMF reviews, and support audits while ensuring compliance with ICH GCP and FDA regulations. This role supports remote work with Boston-area flexibility.

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