Assoc. Director, Data Management

About the role

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most. Reporting to the Senior Director, Biostatistics, the Associate Director will serve as a strategic data management leader across clinical studies. This role will provide end-to-end leadership from protocol review and study start-up through database lock, regulatory submission support, long-term follow-up, and archival, while ensuring high-quality, analysis-ready clinical data. The Associate Director, Clinical Data Management ensures optimized data collection, flow and access across EDC and non-EDC data sources. This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities

• Accountable for data management activities for Kiniksa clinical studies and oversee CRO data management activities that support ongoing clinical programs
• Review protocols and study strategies to ensure feasible, compliant and effective data collection.
• Lead cross-functional data review and align stakeholders on quality, timelines and risk mitigation.
• Provides input to improve data processes and organization in alignment with other development functions
• Develop and maintain SOPs and working practice documents for data management tasks in collaboration with other functions
• Drive study and program milestones, proactively identifying risks and implementing solutions.
• Review clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis)
• Lead EDC database (DB) specification process internally and ensure the database is built to capture the protocol schedule and endpoints
• Review / Develop DB clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations
• Review / Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs
• Oversee the User Acceptance Testing (UAT) by CRO and Coordinating UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report
• Ensure clinical data within EDC is of high quality to support lock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to data reconciliation and/or coding
• Accountable for eDairy, PRO, and other electronic data collection on portable devices to make sure the design of data collection meets the scientific objective
• Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
• Perform close-out audit,