Sr. Manager, Clinical Trial Liaison - Remote
Kiniksa Pharmaceuticals
August 22, 2026
Remote friendly (Raleigh-Durham-Chapel Hill Area)
United States
Clinical Research and Development
Responsibilities:
- Build and maintain productive relationships with Principal Investigators and site personnel; serve as sponsor representative and primary site contact.
- Gather site-level insight to support investigator selection during feasibility.
- Provide protocol and operational training/education (eligibility, visit flow, procedures, recruitment pathways, operational expectations).
- Support recruitment and participant retention initiatives (site-specific plans, patient pathway insights, visit readiness reminders, barrier resolution).
- Monitor site performance vs KPIs (screening, screen failure, enrollment, data quality, documentation risk, action-item closure).
- Track and enable contemporaneous data entry and completeness.
- Oversee CRO CRAs (assess performance, review KPIs/trends, review CRA CVs before assignment, train CRAs; attend key visits).
- Review CRA monitoring visit reports for assigned sites.
- Identify/escalate risks to participant safety, data reliability, protocol compliance, and documentation completeness.
- Support risk-proportionate trial conduct consistent with ICH E6(R3), including quality-by-design and operational feasibility.
- Escalate site operational barriers and issues (data quality, protocol deviations, visit compliance, essential documents, training records, delegation logs, TMF readiness).
- Collaborate with Patient Advocacy to incorporate pathway/community insights into recruitment and retention.
- Contribute to end-of-study lessons learned, barrier analysis, site feedback, and best-practice sharing.
Qualifications & Experience:
- Bachelor’s degree in life science/health science/related field required; nursing or advanced degree preferred.
- 5+ years hands-on clinical trial execution experience.
- Prior study coordinator, CRA, or trial recruitment specialist experience strongly preferred.
- Demonstrated relationship-building with clinical research sites.
- Strong understanding of clinical trial conduct, site operations, GCP, protocol adherence, informed consent process boundaries, and sponsor/CRO/site roles.
- Strong communication, presentation, organization, tracking, and issue-escalation skills.
- Ability to travel frequently, potentially up to ~75%.
Pay Range:
- $170,000–$190,000 USD
- Build and maintain productive relationships with Principal Investigators and site personnel; serve as sponsor representative and primary site contact.
- Gather site-level insight to support investigator selection during feasibility.
- Provide protocol and operational training/education (eligibility, visit flow, procedures, recruitment pathways, operational expectations).
- Support recruitment and participant retention initiatives (site-specific plans, patient pathway insights, visit readiness reminders, barrier resolution).
- Monitor site performance vs KPIs (screening, screen failure, enrollment, data quality, documentation risk, action-item closure).
- Track and enable contemporaneous data entry and completeness.
- Oversee CRO CRAs (assess performance, review KPIs/trends, review CRA CVs before assignment, train CRAs; attend key visits).
- Review CRA monitoring visit reports for assigned sites.
- Identify/escalate risks to participant safety, data reliability, protocol compliance, and documentation completeness.
- Support risk-proportionate trial conduct consistent with ICH E6(R3), including quality-by-design and operational feasibility.
- Escalate site operational barriers and issues (data quality, protocol deviations, visit compliance, essential documents, training records, delegation logs, TMF readiness).
- Collaborate with Patient Advocacy to incorporate pathway/community insights into recruitment and retention.
- Contribute to end-of-study lessons learned, barrier analysis, site feedback, and best-practice sharing.
Qualifications & Experience:
- Bachelor’s degree in life science/health science/related field required; nursing or advanced degree preferred.
- 5+ years hands-on clinical trial execution experience.
- Prior study coordinator, CRA, or trial recruitment specialist experience strongly preferred.
- Demonstrated relationship-building with clinical research sites.
- Strong understanding of clinical trial conduct, site operations, GCP, protocol adherence, informed consent process boundaries, and sponsor/CRO/site roles.
- Strong communication, presentation, organization, tracking, and issue-escalation skills.
- Ability to travel frequently, potentially up to ~75%.
Pay Range:
- $170,000–$190,000 USD