Associate Clinical Project Manager

Reporting to the VP of Clinical Operations or delegate, the Associate Clinical Project Manager (ACPM) will support the planning, execution and delivery of clinical trials in accordance with ICH/GCP and applicable regulatory requirements, timelines, budget, and quality standards. This role will partner closely with Clinical Operations, CROs, vendors, and cross functional stakeholders to ensure efficient trial conduct and issue resolution. The Associate CPM role may be responsible for global or regional study management tasks as assigned by the clinical operations study management team. This role is based in our Lexington, MA office 5 days a week onsite. Responsibilities (including, but not limited to): Trial planning and execution: Support development and maintenance of clinical trial plans, timelines, and milestones Assist with study start-up, including site activation tracking and vendor onboarding Monitor study progress against timelines, identifying risks and escalating issues appropriately Support trial close-out activities and documentation Contribute to site monitoring oversight by tracking and reviewing monitoring visit reports as agreed with the clinical operations study management team Vendor and CRO oversight: Coordinate day-to-day interactions with CROs and vendors Track deliverables and ensure adherence to scope of work Review vendor metrics and support issue resolution Participate in vendor meetings Cross-functional coordination Support with internal study team meeting minuting, tracking and follow up of decisions and actions, and other cross-functional coordination tasks as agreed with the clinical operations study management team Collaborate with the cross-functional team as agreed with the clinical operations study management team Support communication between internal team and external partners Documentation and compliance Assist in development and review of study plans and manuals Support inspection readiness activities and TMF completeness Ensure trial conduct aligns with ICH-GCP, SOPs, applicable regulations, and study plans / manuals Reporting and tracking Maintain study trackers, dashboards, and logs for decision, action and risks Track budgets, invoices, and forecast updates under supervision

Qualifications and Experience:

Requires a Bachelor's Degree in health or biologic science (BS/BA/ BScN or higher) with a minimum of 3 years clinical operations experience in biopharmaceutical industry; global clinical trial experience and rare disease experience is highly preferred Experience in study project management and prior management of contracted resources, including CROs, is required Site monitoring and clinical quality compliance experience are strongly preferred Strong knowledge of Good Clinical Practices; international clinical trial experience and knowledge of other country regulatory requirements is preferred Proficient in use of electronic clinical database software and other programs such as Microsoft Office Salary is commensurate with experience. Kiniksa Benefits Summary - USA The expected salary range for the Associate Clinical Project Manager is $118,000 - $128,000 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.