Kumquat Biosciences Inc.

Manager

• Serve as the CDM lead for one or more clinical programs, accountable for overall data quality, timelines, documentation, and deliverables.
• Represent Data Management in study teams, Biometrics, Clinical Operations, and Regulatory meetings.
• Provide expertise and oversight of all clinical database activities from design/start-up to closeout.
• Reviews protocols for appropriate data capture including electronic (eCRF) design.
• Support CRF design, review, and validation of clinical database.
• Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
• Conducts oversight of data management vendors via ongoing review of quality and performance metrics.
• Generates, resolves, and tracks data queries to ensure the integrity of the clinical data.
• Facilitates and participates in data cleaning activities.
• Generates and/or reviews/approves study documents.
• Responsible for maintaining internal data management timelines and metrics.
• Maintains study DM related documents/files for inspection readiness.
• Proactively identifies potential data management issues/risks and communicates it within the study team for further action.
• Ensure all CDM activities comply with GCP, ICH guidelines, company SOPs, and regulatory requirements.
• Contribute to development and continuous improvement of data standards, processes, and templates.
• Support audit/inspection readiness activities and respond to data-related findings.

Senior Manager, Clinical Data Management

Research Analyst

• Support the study lead(s) in day-to-day operational management of one or more clinical trials.
• Ensure that investigative sites follow the study protocols, Standard Operating Procedures (SOPs), and regulatory requirements.
• May manage one or more key study vendors including central lab, IRT/RTSM, or CRO.
• Monitor and track study progress, patient recruitment, and data collection at investigational sites.
• Review and verify the accuracy, completeness, and quality of clinical trial data.
• Maintain and update essential trial documentation, including case report forms, regulatory documents, and investigator files.
• Collaborate with investigators, study coordinators, and other site staff to provide guidance and support.
• Identify and escalate any issues or deviations from the study plan to the appropriate parties.
• Assist in the preparation and submission of regulatory documents, such as Institutional Review Board (IRB) submissions.
• Ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and relevant regulations.

Clinical Research Associate – In House

Financial Planning and Analysis

• Own the end-to-end clinical trial accrual process, including methodology design, monthly accrual calculations, true-ups, and variance analysis.
• Ensure accurate and timely integration of CRO, EDC, and other clinical data into financial accruals, forecasts, and management reporting.
• Develop and document accrual methodologies, assumptions, and controls to support audit readiness and internal control expectations.
• Serve as the primary finance partner to Clinical Operations and external vendors, ensuring alignment between trial progress, financial assumptions, and spend visibility.
• Lead the implementation, configuration, and continuous improvement of the Clinical Trial Management System (CTMS) in partnership with Clinical Operations and IT.
• Provide financial support for collaboration agreements, including maintaining cost-to-cost inputs and related estimates used for ASC 606 revenue recognition.
• Track reimbursable and shared costs, support forecast updates and assist with audit and valuation-related data requests.
• Partner with Accounting and Legal to ensure financial reporting aligns with contractual and compliance requirements.
• Support budgeting, forecasting, and variance analysis for R&D, clinical programs, and collaboration-related activities.
• Maintain and enhance financial models and analytical tools supporting decision-making by Finance and executive leadership.
• Translate complex financial and operational data into actionable insights that shape R&D investment decisions, trial pacing, and cash runway optimization.
• Gain increasing exposure to executive-level FP&A discussions and strategic planning as the company grows.

Senior Manager, Clinical Data Management

Clinical Research Associate – In House

Manager, Clinical Trial Finance, FP&A