Kiniksapharmaceuticals
Senior Clinical Project Manager
Lexington, MA · Senior
Sponsorship not specified$160k-$180kDetected 48 days ago
GCPProject ManagementNegotiationAccountingForecastingVendor ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationProblem SolvingMicrosoft OfficeBiostatistics
About the role
- Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders.
- At Kiniksa, talented individuals are trusted and empowered to make a real impact-shaping the future of medicine while improving the lives of patients who need it most.
- 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.
Responsibilities
- Leading internal cross-functional study teams and partner with CROs to ensure effective and timely communication, study execution in accordance with the timeline and budget
- Actively participating in protocol design, CRO selection, site selection and IRB/EC applications for early and late phase clinical studies
- 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 forms
- Developing and managing reports for communicating study progress and key metrics to Senior Management and program team
- Ensuring 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 agencies
- Strong expertise in cross-functional project and vendor management, leading CROs and internal stakeholders to deliver studies on time, within budget, and aligned to program goals
Requirements
- Excellent listening, communication (written, spoken) and interpersonal skills, ability to foster team spirit
- Management of non-drug supply ordering and tracking, as required
- Providing oversight and ensuring maintenance of clinical trial master files to ensure their compliance with required regulatory and ICH/GCP quality standards and consistency with SOPs
Nice to have
- A 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 preferred
- Site monitoring and clinical quality compliance experience are strongly preferred
- masters-level degree is preferred
Compensation
- $160,000 - $180,000 USD
- Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.
Benefits
- Requires a Bachelor's Degree in health or biologic science (BS/BA/ BScN or higher); masters-level degree is preferred
- decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Company info
- Stand Out Skills for Impact:
Equal opportunity
- Please contact us to request accommodation.
Visa & Work Authorization
- A 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
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