Clinical Trial Manager

Avalo Therapeutics•Chesterbrook, PA

35d•Hybrid

About The Position

At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process. We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization. Position Summary: 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.

Requirements

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

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