Kiniksa Pharmaceuticals · 1 day ago
Associate Clinical Project Manager
Lexington, MA
Full-time
Onsite
Mid Level
$118K/yr - $128K/yr
3+ years expKiniksa Pharmaceuticals is seeking an Associate Clinical Project Manager (ACPM) to support the planning, execution, and delivery of clinical trials. This role involves collaborating with Clinical Operations, CROs, vendors, and stakeholders to ensure efficient trial conduct and compliance with regulatory standards.
BiopharmaBiotechnologyMedical
Responsibilities
Support development and maintenance of clinical trial plans, timelines, and milestones
Assist with study start-up, including site activation tracking and vendor onboarding
Monitor study progress against timelines, identifying risks and escalating issues appropriately
Support trial close-out activities and documentation
Contribute to site monitoring oversight by tracking and reviewing monitoring visit reports as agreed with the clinical operations study management team
Coordinate day-to-day interactions with CROs and vendors
Track deliverables and ensure adherence to scope of work
Review vendor metrics and support issue resolution
Participate in vendor meetings
Support with internal study team meeting minuting, tracking and follow up of decisions and actions, and other cross-functional coordination tasks as agreed with the clinical operations study management team
Collaborate with the cross-functional team as agreed with the clinical operations study management team
Support communication between internal team and external partners
Assist in development and review of study plans and manuals
Support inspection readiness activities and TMF completeness
Ensure trial conduct aligns with ICH-GCP, SOPs, applicable regulations, and study plans / manuals
Maintain study trackers, dashboards, and logs for decision, action and risks
Track budgets, invoices, and forecast updates under supervision
Qualification
Required
Requires a Bachelor's Degree in health or biologic science (BS/BA/ BScN or higher) with a minimum of 3 years clinical operations experience in biopharmaceutical industry; global clinical trial experience and rare disease experience is highly preferred
Experience in study project management and prior management of contracted resources, including CROs, is required
Proficient in use of electronic clinical database software and other programs such as Microsoft Office
Preferred
global clinical trial experience and rare disease experience is highly preferred
Site monitoring and clinical quality compliance experience are strongly preferred
Strong knowledge of Good Clinical Practices; international clinical trial experience and knowledge of other country regulatory requirements is preferred
Company
Kiniksa Pharmaceuticals
Kiniksa Pharmaceuticals is developing therapies for inflammatory and autoimmune conditions.
201-500 employees
H1B Sponsorship
Kiniksa Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (3)
2022 (4)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$400MKey Investors
Baker Brothers Advisors LLC
2020-05-13Post Ipo Equity· $80M
2018-05-23IPO
2018-02-01Series C· $200M
Leadership Team
Eben Tessari
Chief Operating Officer
Aaron Young
Senior Vice President, Chief Intellectual Property Officer
Recent News
2025-12-09
2025-10-29
2025-10-29
Company data provided by crunchbase