Documentation & Inspection Readiness Manager
Kiniksa Pharmaceuticals, Lexington, MA, United States
Documentation And 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):
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
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.
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
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
The 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.
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):
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
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.
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
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
The 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.