Documentation & Inspection Readiness Manager

Reporting to the VP, Clinical Operations or delegate, the Documentation and Inspection Readiness (DIR) Manager, Clinical Operations is responsible for establishing, overseeing, executing on and continuously improving processes that ensure clinical trial documentation is complete, accurate, inspection-ready, and compliant at all times throughout the lifecycle of Kiniksa’s clinical studies. This role serves as a key operational lead driving Trial Master File (TMF) excellence, documentation quality, and inspection preparedness, working cross-functionally with Clinical Operations, Clinical Development, Quality, Regulatory, and external partners (CROs, vendors).Responsibilities (including, but not limited to):TMF Oversight and Documentation StrategyOwn the strategy and execution of TMF management across all clinical trials (internal and CRO-managed)Define and maintain TMF structure, naming and coding conventions, and filing expectations aligned with regulatory requirements (e.g. ICH E6(R2/3), FDA, EMA, etc).Ensure real-time, contemporaneous filing of essential documents throughout the study lifecycle across all functions and that the TMF is inspection-ready at all times.Establish and track TMF health metrics (completeness, timeliness, quality)Leverage technology (eTMF systems, dashboards, automation) to improve efficiency and visibilityInspection Readiness LeadershipLead the development and implementation of a continuous inspection readiness framework in collaboration with QualityEnsure all studies are maintained in a state of audit readiness at all times throughout the lifecycle of the studyDevelop, maintain and report on inspections readiness metrics and tools (storyboards and narrative summaries, inspection readiness checklists, document trackers, gap assessments,Partner with Quality to support internal audits, mock inspections, regulatory inspections.Documentation Quality and ComplianceDefine standards for document quality, consistency, and completeness across studiesConduct periodic TMF reviews and risk-based quality checksIdentify gaps and drive remediation plans with study teams and CROsEnsure consistency of records and alignment between TMF, CTMS, and other systemsCRO and Vendor OversightOversee CRO TMF performance and documentation deliverablesDefine clear expectations and KPIs for documentation quality and timelinessReview CRO TMF metrics and escalate risks proactivelyEnsure appropriate oversight documentation is maintained (vendor oversight, decisions, communications)Qualifications: At least 5 years of relevant clinical research record management experience in a pharmaceutical, academic, or CRO environmentBachelor's degree or equivalent education in life sciences, record management, public health management, or related fields Experience with electronic TMF systems and technologies, Veeva Vault experience requiredSolid understanding of the clinical trial process; experience in handling clinical trial related documents required and knowledge of Trial Master File Reference Model Structure standardExperience of regulatory inspection strong preferredStrong knowledge of ICH-GCP guidelines, regulatory requirements related to clinical document management, ALCOA+ standard, Good Clinical Practice (GCP), Good Documentation Practices, and International Council for Harmonization (ICH) E6(R2) guidelinesExperience in managing multiple projects and coordinating with cross-functional teamsAbility to prioritize, manage, organize, and maintain large amounts of documentation, both electronic and paperAbility to identify and manage risks and resolve issues in a timely mannerSkilled at problem-solving and proposing solutionsAbility to work independently with minimal direction/oversightEffective communication and interpersonal skillsStrong organizational skills with outstanding attention to detail and follow throughComfortable operating in a fast-paced, evolving environmentStrong commitment to compliance and ethical standardsProficient in the use of Microsoft Office and SharePoint, advanced skills in Excel highly desirableSalary is commensurate with experienceThe expected salary range for Documentation & Inspection Readiness Manager is $140,000 - $148,000 annually. Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.