Avalo Therapeutics

www.avalotx.com

1 Job

47 Employees

About the Company

Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo’s lead asset is AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases.

For more information about Avalo, please visit www.avalotx.com.

Our highly targeted therapeutics have strong scientific and clinical rationale that enable accelerated clinical development and increased probability of success.

We are rapidly advancing a rich pipeline with broad clinical utility across Immunology, Immuno-oncology, and Rare Genetic Diseases.

Our focus is the development of innovative therapies in areas of high unmet need within the fields of Rare Pediatric and Orphan Diseases.

Listed Jobs

Company Name: Avalo Therapeutics
Job Title: Senior Manager, Data Management
Job Description: **Job Title:** Senior Manager, Data Management (Contractor) **Role Summary:** Lead clinical data management for one or more drug development programs, ensuring data quality, integrity, and regulatory compliance from study start‑up through database lock and submission readiness. Collaborate with cross‑functional teams, oversee vendor activities, and drive process improvements to support clinical decision‑making and regulatory submissions. **Expectations:** - Deliver complete, accurate, and audit‑ready data sets for regulatory dossiers. - Manage project timelines, deliverables, and vendor performance. - Ensure adherence to ICH/FDA, CDISC CDASH, GCP, and related standards. - Facilitate cross‑functional reviews and provide data insights to study teams. **Key Responsibilities:** - Consult on protocol design for data capture alignment with study objectives. - Oversee data management deliverables, timelines, and quality checkpoints. - Conduct periodic data reviews with clinical, biostatistics, and medical teams. - Support database build: EDC documentation review, UAT, and closure activities. - Develop and maintain study data plans, ensuring completeness of data entry. - Evaluate RFPs, assess vendor qualifications, and negotiate contracts. - Manage data transfer agreements and reconcile third‑party data. - Perform data reconciliation (e.g., SAE, laboratory) and ensure SAP mock listings reflect real data. - Review clinical study reports, tables, and listings for consistency. - Facilitate dictionary coding (MedDRA, WHO‑Drug) and protocol deviation reviews. - Maintain TMF documentation related to data management. **Required Skills:** - Excellent written and verbal communication. - Strong organizational skills with meticulous attention to detail. - Proactive problem‑solving and decision‑making. - Collaborative ability with internal and external stakeholders. - Independent work capability. - Proficiency in Microsoft Office and eCRF/EDC systems. - Comprehensive understanding of regulatory guidance (ICH/FDA, CDISC CDASH, GCP, 21 CFR 11, MedDRA, WHO‑Drug). **Required Education & Certifications:** - Bachelor’s degree in a scientific or technical discipline. - 5+ years of data management experience in a pharmaceutical or CRO setting (small‑company experience a plus). *All other details omitted for brevity.*