Senior Manager, Data Management

*** This position will initially be a 6-month contract position***

At Avalo (ahh-vah'-low), we’re 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.

The Senior Manager, Data Management (Contractor) is responsible for the clinical data management activities across one or more development programs. This role is responsible for ensuring the quality, integrity, timeliness, and regulatory compliance of clinical trial data from study start-up through database lock and submission readiness. Working in close collaboration with Clinical Operations, Medical, Biostatistics, Regulatory, IT, and external vendors/CROs, the contractor supports the delivery of high-quality data to enable sound decision-making and regulatory submissions.

• Consult on protocol development to ensure delivery of study data to support protocol objectives and endpoints
• Oversee DM deliverables and timelines for clinical studies
• Contribute to periodic data reviews with clinical study team to ensure sponsor oversight, and delivery of accurate, consistent and reliable data
• Support database build during study start up, including review of EDC documentation and UAT activities, as well as database closure activities at study end
• Participate in the development of study plans related to data delivery to ensure accurate and complete study data
• Review RFP’s for clinical studies and collaborate on assessment of vendor qualifications, as applicable
• Review vendor contracts to ensure delivery of required data components for submissions and/or audits
• Facilitate data transfer agreements with external vendors and oversee reconciliation of third-party data
• Provide input into statistical analysis plan (SAP) mock listings, and ensure there is an accurate reflection of data collection
• Contribute to review of clinical study reports, including review of tables and listings for any inconsistencies with data management during course of studies.
• Provide study data as needed by study teams to support study activities
• Facilitate and manage dictionary (MedDRA, WHODRUG) coding activities and support protocol deviation review.
• Review TMF documentation related to data management activities.

• Bachelor’s degree in related scientific or technical discipline
• At least 5+ years’ experience in data management in a pharmaceutical or CRO environment, small company experience a plus

• Excellent verbal and written communication skills
• Highly organized with a strong attention to detail
• Strong collaboration skills in working with external and internal cross-functional teams
• Demonstrated proactive approach to problem solving with strong decision-making capability
• Forward looking thinker, who seeks opportunities to improve processes
• Ability to work independently
• Highly proficient in Microsoft Office and eCRF systems
• Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC CDASH standards, GCDMP, 21 CRF 11, MedDRA, WHO Drug), and their application to Data Management

Contractor (6 months with potential to renew/convert)

Hybrid;
This role offers a flexible work arrangement but may require travel to corporate headquarters and attendance at customer-facing meetings, as needed.

Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead asset, AVTX-009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact…