Clinical Trial Manager

Overview 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. 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. About Avalo Therapeutics Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing therapeutics targeting the IL-1β pathway for immune‑mediated inflammatory diseases. Our lead asset, abdakibart, is an anti‑IL‑1β monoclonal antibody (mAb). Positive topline data was recently reported for abdakibart in a Phase 2 clinical trial in hidradenitis suppurativa (HS). In addition to HS, we’re exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. We are also advancing AVTX‑010, a long‑acting next‑generation anti‑IL‑1β mAb designed to extend dosing intervals and build upon the differentiated profile established by abdakibart. For more information about Avalo, please visit #J-18808-Ljbffr