Clinical Trial Manager

Position Summary:

Reporting to the ED of Clinical Development Operations or delegate, the Clinical Trial Manager (CTM) will support the planning, execution and delivery of clinical trials in accordance with Avalo Therapeutics SOPs, ICH/GCP and applicable regulatory requirements, timelines, budget, and quality standards. This role will partner closely with the Clinical Operations study management team to ensure efficient study management.

Reporting to the Executive Director of Clinical Development Operations (or delegate), the Clinical Trial Manager (CTM) plays a key role in the planning, execution, and delivery of clinical trials. This role supports studies in alignment with Avalo Therapeutics’ SOPs, ICH/GCP guidelines, and applicable regulatory requirements, while maintaining high standards for quality, timelines, and budget. The CTM collaborates closely with cross-functional partners and vendors to support efficient, patient-focused study execution.

Main Responsibilities:

• Support and/or lead key aspects of clinical trial operations, including vendor management, site start-up, and monitoring activities
• Contribute to the development, review, and maintenance of study documents (e.g., protocols, amendments, informed consent forms, monitoring plans, study manuals, eCRFs, IVRS/IWR systems)
• Foster clear, respectful, and proactive communication between internal teams and external partners, ensuring alignment on study goals and expectations
• Identify, communicate, and help resolve study-related risks and issues in a timely and thoughtful manner
• Support the development, management, and negotiation of clinical site budgets
• Track and support site activation progress, partnering with CROs and internal stakeholders to address barriers and improve timelines
• Review vendor invoices and help monitor for trends or scope changes
• Contribute to monitoring oversight activities, including review of trip reports and monitoring plans
• Support site identification, feasibility assessments, and site selection processes
• Participate in cross-functional project teams and contribute to collaborative decision-making
• Build and maintain strong, respectful relationships with vendors, CROs, and clinical sites
• Support planning and execution of Investigator Meetings and training activities
• Contribute to risk assessment and development of mitigation strategies
• Assist with clinical supplies planning, including forecasting and accountability support
• Ensure accurate and timely filing of study documentation in CTMS and/or eTMF systems
• Support audit and inspection readiness activities
• Ensure compliance with clinical trial registry requirements and applicable SOPs

Education & Experience:

• Bachelor’s degree in a relevant field or equivalent combination of education and experience
• Approximately 5+ years of experience in clinical research or clinical operations within biotech, biopharma, or related environments
• Strong organizational and time management skills, with the ability to manage multiple priorities
• Effective communication skills, with the ability to clearly convey information across diverse teams and stakeholders
• Experience contributing to or managing study documentation
• Proactive problem-solving skills and ability to adapt in a dynamic environment
• Working knowledge of ICH/GCP and applicable regulatory guidelines
• Experience working with vendors and cross-functional teams
• Ability to build collaborative, inclusive, and respectful working relationships
• Familiarity with clinical systems such as EDC, IVRS/IWR, CTMS, and Microsoft Office tools
• Commitment to integrity, professionalism, and patient-centered clinical research

Travel Requirement: Up to 25%

Location: This position is based in Chesterbrook, PA and offers a flexible hybrid work model with a minimum of 2 days/week in the office.