Sr. Manager, Clinical Trial Liaison - Remote

About Kiniksa Pharmaceuticals

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. 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.

Position Summary

The CTL at CSSE Senior Manager level is responsible for site-facing engagement and operational support for assigned studies, regions, or priority sites. This role focuses on building strong relationships with investigative sites, identifying barriers to screening and enrollment, supporting protocol and operational education, ensuring contemporaneous and accurate data entry, and escalating site-level risks that may impact study execution, participant retention, data quality, or documentation readiness.

The Senior Manager CTL is expected to work independently with assigned sites while partnering closely with Clinical Operations study teams, CRO personnel, Medical Affairs, Patient Advocacy, and other cross-functional partners. The role expands beyond recruitment to include sustained site engagement, operational intelligence, issue identification, risk mitigation, and contribution to continuous improvement.

Responsibilities (including, but not limited to):

Site Oversight

• Build and maintain productive relationships with Principal Investigators, study coordinators, research nurses, site managers, and other relevant site personnel, and serve as a sponsor representative and primary site engagement contact for assigned sites.
• Gather site-level insight on patient availability, recruitment pathways, operational readiness, competing studies, site capacity, and prior performance to support investigator selection during feasibility.
• Provide protocol and operational training/education to sites, including eligibility criteria, visit flow, study procedures, recruitment pathways, and operational expectations, to ensure adherence to the study protocol and clear understanding of overall operational setup of the study.
• Support recruitment and study participant retention initiatives, including site-specific recruitment plans, community/patient pathway insights, participant retention planning, visit readiness reminders, and barrier resolution.
• Monitor assigned site performance against agreed KPIs, screening activity, screen failure trends, enrollment performance, data cleaning and quality, documentation risk, and action-item closure.
• Track and enable contemporaneous data entry and completeness.

CRO Oversight

• Oversee CRO Clinical Research Associates (CRAs) through assessment of performance, review of trends and KPIs, review of CVs of CRA before assignment, training of CRAs, etc.
• Attend qualification, initiation, interim, engagement, or closeout visits, either remotely or in person, as appropriate to oversee CRA performance.
• Review CRA monitoring visit reports for assigned sites.

Study Team Collaboration

• Support sponsor oversight by identifying and escalating risks to participant safety, data integrity, or study execution.