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 Strategy

• Own 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 visibility
  
  

Inspection Readiness Leadership

• Lead the development and implementation of a continuous inspection readiness framework in collaboration with Quality
• Ensure all studies are maintained in a state of audit readiness at all times throughout the lifecycle of the study
• Develop, 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 Compliance

• Define standards for document quality, consistency, and completeness across studies
• Conduct periodic TMF reviews and risk-based quality checks
• Identify gaps and drive remediation plans with study teams and CROs
• Ensure consistency of records and alignment between TMF, CTMS, and other systems
  
  

CRO and Vendor Oversight

• Oversee CRO TMF performance and documentation deliverables
• Define clear expectations and KPIs for documentation quality and timeliness
• Review CRO TMF metrics and escalate risks proactively
• Ensure 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 environment
• Bachelor'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 required
• Solid understanding of the clinical trial process; experience in handling clinical trial related documents required and knowledge of Trial Master File Reference Model Structure standard
• Experience of regulatory inspection strong preferred
• Strong 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) guidelines
• Experience in managing multiple projects and coordinating with cross-functional teams
• Ability to prioritize, manage, organize, and maintain large amounts of documentation, both electronic and paper
• Ability to identify and manage risks and resolve issues in a timely manner
• Skilled at problem-solving and proposing solutions
• Ability to work independently with minimal direction/oversight
• Effective communication and interpersonal skills
• Strong organizational skills with outstanding attention to detail and follow through
• Comfortable operating in a fast-paced, evolving environment
• Strong commitment to compliance and ethical standards
• Proficient in the use of Microsoft Office and SharePoint, advanced skills in Excel highly desirable
• Salary is commensurate with experience
• Kiniksa Benefits Summary - USA
  
  

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.