Senior Clinical Project Manager

Responsibilities

• Independently manage all operational aspects for clinical trial implementation from study start-up through database lock
• Lead internal cross-functional study teams and partner with CROs to ensure timely execution within timeline and budget
• Participate in protocol design, CRO selection, site selection, and IRB/EC applications
• Manage study-related vendors and serve as the primary point of contact for contracted CROs and labs
• Perform or oversee site monitoring visits for clinical trials as needed
• Facilitate completion of study protocols and development of electronic clinical trial systems like EDC and IRT
• Provide input into and develop study materials including Clinical Monitoring Plans, Data Management Plans, and eCRF forms
• Review monitoring reports, protocol deviations, and data listings to ensure quality
• Coordinate site budgets and provide oversight for site payments
• Ensure inspection readiness and support sites for clinical audits and regulatory inspections

Requirements

• Bachelor’s Degree in health or biologic science (BS/BA/BScN or higher); Master's preferred
• Minimum 7 years of clinical operations experience at a sponsor or CRO
• Minimum 3 years as a clinical study lead or project manager
• Required experience with global clinical trials
• Advanced knowledge of Good Clinical Practices (GCP) and FDA regulations for IND clinical trials
• Extensive experience selecting and managing CROs and clinical trial vendors
• Proficiency in electronic clinical database software and Microsoft Office

Preferred Qualifications

• Experience with cardiovascular, rare disease, or Phase 1 studies
• Experience with site monitoring and clinical quality compliance
• Knowledge of preparation for regulatory submissions such as INDs, CTAs, BLAs, MAAs, or NDAs

About the Company

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.