Senior Project Manager

Position Overview

• Location Type: Remote
• Employment Type: Full Time
• Salary: (Salary not provided in the description)

This role is within the Alira Health Clinical team, focused on ensuring the efficient implementation of study protocols and collaborating with sponsors and vendors. The SCPM plays a key role in managing clinical research studies, providing guidance to the Clinical team, and maintaining compliance with regulatory guidelines.

Requirements

• Bachelor’s degree in a life science or related discipline (preferred).
• 10 years of experience in the pharmaceutical, biotechnology, or CRO industry.
• At least 5 years of clinical project management experience.

Responsibilities

• Manages clinical research studies according to approved scope, budget, ICH GCP guidelines, and FDA regulations.
• Serves as the primary contact for sponsors.
• Manages clinical study functions, including:
  • Investigational Supply
  • IWRS/IXRS
  • Data Management
  • Biostatistics
  • Pharmacovigilance
  • Central Laboratory
• Generates and presents study status updates and reports to sponsors.
• 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 guidance to CPMs.
• Creates and reviews clinical study documents:
  • Protocols
  • ICF Templates
  • Study Budgets
  • Site Log/Form Templates
  • Study Manuals and Plans
  • Site Binders
• Drives clinical teamwork and communications to ensure timely milestone attainment.
• Ensures accuracy of reports and material work product.
• Provides monthly billing information to the finance team.
• Presents at project meetings (investigator meetings, new client meetings).
• Identifies issues and develops problem-solving strategies to meet study timelines.
• Manages subject accrual, retention, and compliance.
• Assists in TMF management and manages TMF reviews.
• 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.

Application Instructions

• Refer to the referral link emailed to you if you have been referred to this role.

Company Information

• Company: Alira Health
• Team: Clinical Team
• Values: Be courageous, be accountable, be honest, be inclusive, and elevate others.