Clinical Operations Senior Manager
Kiniksa Pharmaceuticals
August 22, 2026
On-site
Lexington, MA
Clinical Research and Development
Responsibilities:
- Independently manage clinical trial operational activities from start-up through database lock, accelerating project launch and site start-up/activations while ensuring protocol, GCP, and SOP adherence.
- Lead internal cross-functional study teams and partner with CROs for effective, timely communication and execution within timeline and budget.
- Participate in protocol design, CRO and site selection, and IRB/EC submissions for early and late-phase studies.
- Manage vendors/CROs and serve as primary point of contact; identify risks, resolve issues, manage vendor plans, and review quality metrics.
- Perform/oversee site monitoring visits as needed.
- Support protocol amendments and development/revision of eClinical systems (e.g., EDC, IRT).
- Develop/coordinate study materials (Clinical Monitoring/Data Management Plans, eCRF and guidelines, protocols, consent drafts, specimen instructions, drug order forms).
- Review monitoring reports, protocol deviations, and data listings for quality.
- Coordinate CROs for site selection, IRB submissions, initiation, and close-out.
- Create/manage reports on study progress and key metrics for Senior Management and program teams.
- Coordinate site budget negotiations and oversee site payments.
- Facilitate study drug ordering and drug chain record/accountability; manage non-drug supply ordering/tracking as required.
- Oversee maintenance of clinical trial master files for regulatory/ICH-GCP compliance.
- Provide input to IND filings, CTAs, safety reports, clinical study reports, and ICH-compliant dossier sections (BLA/MAA/NDA, etc.).
- Ensure adverse events/product safety issues are captured and evaluated timely.
- Forecast/reforecast investigational product needs and communicate routinely.
- Support inspection readiness and audits/inspections with CROs and sites; respond to findings.
Qualifications:
- BS/BA/BScN or higher in health/biologic sciences (Master’s preferred).
- 7+ years clinical operations experience (sponsor or CRO), including 3 years as clinical study lead/project manager.
- Global experience required; cardiovascular, rare disease, and/or Phase 1 experience preferred.
- Experience managing domestic/international Phase 1–3 trials and investigational site start-up.
- Strong project and risk management.
- Excellent written/spoken communication and interpersonal skills.
- Site monitoring and clinical quality compliance experience strongly preferred.
- Advanced GCP knowledge and working knowledge of FDA IND regulations and other country requirements.
- Extensive CRO/vendor selection and management experience.
- Experience delivering clinical study reports and preparing regulatory clinical sections (IND/CTA/BLA/MAA/NDA; eCTD Module 1 data).
- Ability to forecast/manage budgets across studies.
- Proficiency with electronic clinical database software and Microsoft Office.
Required onsite:
- Lexington, MA office; onsite five days/week.
- Independently manage clinical trial operational activities from start-up through database lock, accelerating project launch and site start-up/activations while ensuring protocol, GCP, and SOP adherence.
- Lead internal cross-functional study teams and partner with CROs for effective, timely communication and execution within timeline and budget.
- Participate in protocol design, CRO and site selection, and IRB/EC submissions for early and late-phase studies.
- Manage vendors/CROs and serve as primary point of contact; identify risks, resolve issues, manage vendor plans, and review quality metrics.
- Perform/oversee site monitoring visits as needed.
- Support protocol amendments and development/revision of eClinical systems (e.g., EDC, IRT).
- Develop/coordinate study materials (Clinical Monitoring/Data Management Plans, eCRF and guidelines, protocols, consent drafts, specimen instructions, drug order forms).
- Review monitoring reports, protocol deviations, and data listings for quality.
- Coordinate CROs for site selection, IRB submissions, initiation, and close-out.
- Create/manage reports on study progress and key metrics for Senior Management and program teams.
- Coordinate site budget negotiations and oversee site payments.
- Facilitate study drug ordering and drug chain record/accountability; manage non-drug supply ordering/tracking as required.
- Oversee maintenance of clinical trial master files for regulatory/ICH-GCP compliance.
- Provide input to IND filings, CTAs, safety reports, clinical study reports, and ICH-compliant dossier sections (BLA/MAA/NDA, etc.).
- Ensure adverse events/product safety issues are captured and evaluated timely.
- Forecast/reforecast investigational product needs and communicate routinely.
- Support inspection readiness and audits/inspections with CROs and sites; respond to findings.
Qualifications:
- BS/BA/BScN or higher in health/biologic sciences (Master’s preferred).
- 7+ years clinical operations experience (sponsor or CRO), including 3 years as clinical study lead/project manager.
- Global experience required; cardiovascular, rare disease, and/or Phase 1 experience preferred.
- Experience managing domestic/international Phase 1–3 trials and investigational site start-up.
- Strong project and risk management.
- Excellent written/spoken communication and interpersonal skills.
- Site monitoring and clinical quality compliance experience strongly preferred.
- Advanced GCP knowledge and working knowledge of FDA IND regulations and other country requirements.
- Extensive CRO/vendor selection and management experience.
- Experience delivering clinical study reports and preparing regulatory clinical sections (IND/CTA/BLA/MAA/NDA; eCTD Module 1 data).
- Ability to forecast/manage budgets across studies.
- Proficiency with electronic clinical database software and Microsoft Office.
Required onsite:
- Lexington, MA office; onsite five days/week.