Documentation & Inspection Readiness Manager

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    "requisitionDescription": "<div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;' data-pasted=\"true\"><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">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&rsquo;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).</span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:12.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\"><strong>Responsibilities <em>(including, but not limited to)</em>:</strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\"><strong>TMF Oversight and Documentation Strategy</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Own the strategy and execution of TMF management across all clinical trials (internal and CRO-managed)</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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).</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Establish and track TMF health metrics (completeness, timeliness, quality)</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Leverage technology (eTMF systems, dashboards, automation) to improve efficiency and visibility</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\"><strong>Inspection Readiness Leadership</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Lead the development and implementation of a continuous inspection readiness framework in collaboration with Quality</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ensure all studies are maintained in a state of audit readiness at all times throughout the lifecycle of the study</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Develop, maintain and report on inspections readiness metrics and tools (storyboards and narrative summaries, inspection readiness checklists, document trackers, gap assessments,</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Partner with Quality to support internal audits, mock inspections, regulatory inspections.</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\"><strong>Documentation Quality and Compliance</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Define standards for document quality, consistency, and completeness across studies</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Conduct periodic TMF reviews and risk-based quality checks</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Identify gaps and drive remediation plans with study teams and CROs</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ensure consistency of records and alignment between TMF, CTMS, and other systems</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\"><strong>CRO and Vendor Oversight</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Oversee CRO TMF performance and documentation deliverables</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Define clear expectations and KPIs for documentation quality and timeliness</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Review CRO TMF metrics and escalate risks proactively</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ensure appropriate oversight documentation is maintained (vendor oversight, decisions, communications)</li></ul></div><p style='margin-top:12.0pt;margin-right:0in;margin-bottom:12.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\"><strong>Qualifications:&nbsp;</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: -0.25in;\"><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">At least 5 years of relevant clinical research record management experience in a pharmaceutical, academic, or CRO environment</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Bachelor&#39;s degree or equivalent education in life sciences, record management, public health management, or related fields&nbsp;</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Experience with electronic TMF systems and technologies, Veeva Vault experience required</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Experience of regulatory inspection strong preferred</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Experience in managing multiple projects and coordinating with cross-functional teams</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ability to prioritize, manage, organize, and maintain large amounts of documentation, both electronic and paper</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ability to identify and manage risks and resolve issues in a timely manner</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Skilled at problem-solving and proposing solutions</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ability to work independently with minimal direction/oversight</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Effective communication and interpersonal skills</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Strong organizational skills with outstanding attention to detail and follow through</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Comfortable operating in a fast-paced, evolving environment</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Strong commitment to compliance and ethical standards</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Proficient in the use of Microsoft Office and SharePoint, advanced skills in Excel highly desirable</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Salary is commensurate with experience</li></ul><p><span style=\"font-size: 14px; color: rgb(0, 0, 0); font-family: arial, sans-serif;\" data-pasted=\"true\">The expected salary range for Documentation &amp; 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.</span></p></div><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"color: rgb(0, 0, 0); font-family: arial, sans-serif; font-size: 14px;\">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.</span></p></div>\n",
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