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Alira Health · 6 hours ago

Senior Project Manager

United States

Full-time

Remote

Senior Level, Lead/Staff

10+ years exp

Alira Health is a global team dedicated to innovation and initiative, seeking a Senior Project Manager for their Clinical team. The role involves managing clinical research studies, ensuring compliance with regulations, and leading communication with sponsors and vendors.

BiotechnologyConsultingHealth Care

No H1B

Responsibilities

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 provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates

Supervises and trains Associate CPMs and provides ongoing support and high-level guidance to CPMs

Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc

Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones

Ensures accuracy of reports and material work product

Provides monthly billing information to finance team

Presents at project meetings such as investigator meetings and new client meetings

Updates management accurately and regularly through frequent communication

Identifies issues and develops problem-solving strategies to ensure study timelines are met

Manages subject accrual, retention, and compliance

Assists in TMF management and manages TMF reviews as needed

Prepares for and participates in third-party audits and FDA inspections

Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs

Participates in internal, client/sponsor, scientific, and other meetings as required

Performs additional duties as assigned

Qualification

Clinical project managementPharmaceutical industry experienceRegulatory compliance ICH GCPRegulatory compliance FDAMS Office SuiteLeadership skillsAnalytical skillsMeeting managementCustomer service orientationEnglish proficiencyNegotiation skillsInterpersonal skillsProblem-solvingOrganizational skills