Sr. Manager​/Associate Director, Data Management

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:

Senior Manager / Associate Director, Clinical Data Management to provide leadership and oversight of clinical data management activities across one or more development programs. This individual will be 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 closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, clinical pharmacology, Pharmacovigilance, Regulatory Affairs, Information Technology, and external partners, this role will serve as the Data Management lead for assigned studies and programs, driving data strategy, vendor oversight, process excellence, and inspection readiness to support informed decision‑making and successful regulatory submissions.

Essential Duties and Responsibilities:

Clinical Data Management Leadership

• Lead clinical data management activities for assigned studies (especially for PK trials) from protocol development through database lock and submission readiness;
  Serve as the primary point of contact for CROs and vendors, ensuring data are delivered on time, within budget, and in compliance with ICH‑GCP guidelines.
• Represent Data Management on cross‑functional study teams, ensuring alignment of data management deliverables with study objectives, timelines, and regulatory requirements.
• Develop and execute study‑specific data management strategies to ensure high‑quality, analyzable clinical trial data.
• Oversee and maintain Data Management Plans (DMPs), data review plans, and other study‑level documentation.

Database Design, Build, and Validation

• Collaborate with Clinical Development, Biostatistics, and Medical/Clinical Pharmacology teams to design and review electronic Case Report Forms (eCRFs).
• Develop and review database build specifications, edit check specifications, CRF completion guidelines, and validation plans.
• Lead User Acceptance Testing (UAT) activities and oversee database go‑live readiness.
• Ensure databases are designed and validated in accordance with protocol requirements, CDASH standards, and industry best practices.

Data Review and Quality Oversight

• Lead ongoing PK data and other data review, discrepancy management, query generation and resolution activities.
• Establish and monitor data quality metrics to ensure data accuracy, consistency, completeness, and readiness for analysis.
• Oversee reconciliation activities including Serious Adverse Events (SAEs), laboratory data, medical coding, protocol deviations, and other external data sources.
• Manage MedDRA and WHODrug coding activities and ensure consistency across studies.
• Support database lock activities and final data transfers for statistical analysis and regulatory submissions.

Vendor and CRO Management

• Manage bioanalytical vendors for PK assay and ensure appropriate data collection to support PK clinical trial execution.
• Provide oversight of CROs, EDC providers, specialty laboratories, and other external vendors responsible for data management deliverables.
• Participate in vendor selection activities, including RFP reviews and vendor assessments.
• Review vendor contracts, data transfer agreements, and service deliverables to ensure compliance with study and regulatory requirements.
• Monitor vendor performance, timelines, quality metrics, and issue resolution.

Cross‑Functional Collaboration

• Partner closely with Biostatistics and Statistical Programming to support data review, SAP development, listings review, and…