Expanded Access Program Manager

Company Description

EVR Consulting LLC is a boutique business-technology consulting firm that collaborates with specialty pharmaceutical and biotechnology companies. We provide services designed to complement our clients' existing in-house capabilities. Our expertise lies in delivering tailored solutions to meet the unique needs of our clients.

Role Description

This is a contract, remote role for an Expanded Access Program Manager. The Expanded Access Program Manager will oversee and manage expanded access programs, ensuring regulatory compliance and proper documentation. The role involves coordinating with various stakeholders, developing program protocols, and monitoring patient enrollment and treatment. The candidate will also be responsible for maintaining clear and consistent communication with clients and healthcare professionals.

Key Responsibilities

1. Site Onboarding and Activation

• Manage documentation for site onboarding process including site agreements, budgets, informed consent forms, and protocol documentation.
• Ensure timely review and approval of all documents with Legal and Medical Affairs.
• Support Medical Affairs and Program Vendor with site documentation needs.

2. Specialty Pharmacy Management

• Serve as the main point of contact for the EAP program.
• Lead weekly meetings to track site onboarding, patient enrollment, dispensing activity, and operational performance.
• Monitor and review Program Vendor reports (weekly and monthly) and recommend improvements to ensure proper tracking of program participants.
• Ensure safety data and compliance reporting aligns with SOPs and contractual obligations.

3. Stakeholder Coordination & Communication

• Maintain and update site and patient trackers.
• Facilitate clear and timely communication across sites, caregivers, pharmacy, and internal teams.
• Ensure communication and alignment across all stakeholders.

4. Data Management & Compliance

• Work with Program Vendor to ensure complete and accurate data capture per protocol requirements.
• Support Corporate data and reporting requests as needed.
• Confirm safety reporting workflows are followed consistently.

5. Education & Process Optimization

• Identify and make recommendations for educational needs for sites, caregivers, and pharmacy staff.
• Promote protocol adherence and streamline EAP processes for efficiency and quality.

Qualifications

• Experience in managing expanded access programs, regulatory compliance, and program protocols
• Skills in stakeholder coordination, patient enrollment, and treatment monitoring
• Proficiency in clear and consistent communication with clients and healthcare professionals
• Ability to work independently and remotely
• Knowledge of the pharmaceutical and biotechnology industries
• Bachelor's degree in a related field; advanced degree is a plus
• Experience in project management or clinical trials management is beneficial