Company Overview:

Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 2 study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Overview:

The Clinical Trial Assistant will provide general administrative and project support for clinical research studies. He/she will provide day-to-day operational support to the Clinical Operations and Study Management teams across Avalyn’s clinical trials spanning PH 1-2b and beyond. This role will support study start-up, ongoing study conduct, and close-out activities in close collaboration with CRO partners, external vendors, and internal cross-functional teams. The Clinical Trial Assistant will help coordinate global clinical trial activities by tracking key study milestones, deliverables, and timelines across investigational sites, and will assist in the preparation and organization of study materials for Investigator Meetings, Site Initiation Visits (SIVs), and other study-related meetings and communications.

Responsibilities:

· Support TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC and reconciliation (through life of the trial and final reconciliation) Including conducting TMF audits based on the timing outlined in the applicable study plans

communicating issues identified to the CRO and tracking resolution of the identified issues.

· Create and maintain a SharePoint study file organization structure; build a file folder format consistent with TMF reference model to use consistently across all trials.

· Assist with study start-up, maintenance, and close-out activities in collaboration with CROs, vendors, and internal cross-functional teams.

· Responsible for coordination of meetings and generate meeting minutes

· Will assist in building Smartsheet or similar workspaces to house various study specific trackers allowing for a central location

· Responsible for supporting Data Review, identifying gaps/missing data, outliers, etc) to ensure accuracy of data. Track and report status of issues to resolution, escalating when appropriate.

· Support GCP compliance and inspection readiness activities by ensuring study documentation is complete, accurate, and well organized.

· Assist with internal audits, inspection preparation activities, and responses to audit findings as needed.

Required Qualifications:

· Minimum of Bachelor’s degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related field (or equivalent relevant experience)

· 2+ years of experience in Clinical Operations, Clinical Research, or a related clinical trial support role (industry or CRO)

· Working knowledge of clinical trial documentation and Trial Master File (TMF) requirements including the CDISC TMF reference model

· Experience supporting TMF activities, including document collection, filing, tracking, and basic QC

· Familiarity with electronic TMF (eTMF) systems and document management best practices

· Experience with TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC (set a frequency through life of the trial and final recon)

· Ability to build, maintain, and update study trackers (e.g., Excel, Smartsheet, or similar tools)

· Strong attention to detail with the ability to identify missing, inconsistent, or incomplete information

· Excellent organizational, time management, and prioritization skills

· Strong written and verbal communication skills, including the ability to document meeting minutes clearly and concisely

· Ability to work collaboratively, as well as independently. with cross-functional teams, CROs, and external vendors

· Must be familiar with ICH GCP and appropriate regulations

· Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)