The Senior Clinical Project Manager will provide operational expertise within the Research and Development function to ensure timely initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the United States and global markets.  This role will work closely and collaboratively with Program Management, Data Management, Clinical Development, Medical Writing, Biostatistics, Clinical Supply, Global Medical Safety, GCP Quality and Regulatory staff as well as Clinical Research Organizations, to ensure the timely execution of studies within budget. Emphasis will be on superior execution, transparency within the department and to Senior Management, and ability to employ cost effective measures and stewardship relative to clinical trial cost projections and final accounting for company.This role is based in our Lexington, MA office 5 days a week onsite. Responsibilities (including, but not limited to):Independently managing all operational aspects for implementation of clinical trial activities from study start-up through database lock, with expertise in accelerating project launch and site start-up / activations, while ensuring adherence to protocol, GCPs and relevant SOPsLeading internal cross-functional study teams and partner with CROs to ensure effective and timely communication, study execution in accordance with the timeline and budgetActively participating in protocol design, CRO selection, site selection and IRB/EC applications for early and late phase clinical studiesManaging study-related vendors and serving as the primary point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metricsPerforming and/or overseeing site monitoring visits for clinical trials as neededFacilitating the timely completion of study protocols (including amendments) and development (and revision) of electronic clinical trial systems (e.g., EDC, IRT)Providing input into and/or developing study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and study drug order formsReviewing monitoring reports, protocol deviations and data listings for sponsored studies to ensure reliable quality data are deliveredCoordinating with CROs on site selection, IRB submissions, site initiation and close-out planningManaging in a timely and efficient manner all operational aspects of protocol amendmentsDeveloping and managing reports for communicating study progress and key metrics to Senior Management and program teamCoordinating the negotiation of site budgets within guidelines and providing oversight for site payments per contractsFacilitating site study drug orders, and ensuring full drug chain record management, including site accountability records are maintained; Management of non-drug supply ordering and tracking, as requiredProviding oversight and ensuring maintenance of clinical trial master files to ensure their compliance with required regulatory and ICH/GCP quality standards and consistency with SOPsProviding input to Drug (IND) filings, Clinical Trial Applications, safety reports, clinical study reports and other ICH compliant sections of registration dossiers (e.g., BLA, MAA, NDA, etc.)Providing oversight of clinical trials to ensure that all adverse events or product safety issues are captured, reported and evaluated by appropriate Clinical personnel in a timely mannerEstablishing a system and procedure for forecasting (and reforecasting) needs for investigational product for each study and communicating those needs on a routine basisEnsuring inspection readiness and participating with CROs and providing support to sites to prepare for clinical audits/inspections and to respond to audit/inspection findings conducted by internal QA and external regulatory agenciesQualifications and Experience:Requires a Bachelor’s Degree in health or biologic science (BS/BA/ BScN or higher); masters-level degree is preferredA minimum of 7 years clinical operations experience at a sponsor or CRO, including 3 years as a clinical study lead / project manager is required; global clinical trial experience is required with cardiovascular, rare disease and/or Phase 1 experience highly preferredSolid well-grounded experience in setup, execution and operational management of domestic and international Phase 1, 2, and/or 3 clinical trials across an array of therapeutic areas, including expertise in all aspects of investigational site start-upEffective project management and risk management skillsExcellent listening, communication (written, spoken) and interpersonal skills, ability to foster team spiritSite monitoring and clinical quality compliance experience are strongly preferredAdvanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials is required; working knowledge of other country regulatory requirements is requiredExtensive experience selecting and managing CROs and clinical trial vendorsExtensive experience in delivering clinical study reports with applicable appendicesKnowledge and experience in preparation of clinical sections of regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs or NDAs), including data needed for completion of sections in eCTD Module 1Ability to accurately forecast budgets and manage them across studies and projectsProficient in use of electronic clinical database software and other programs such as Microsoft OfficeSalary is commensurate with experienceKiniksa Benefits Summary - USAThe expected salary range for the Senior Clinical Project Manager is $160,000 - 180,000 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.