Senior Clinical Trial Manager – Early-Phase Immunology

Seismic Therapeutic Inc

Watertown (MA)

On-site

USD 130,000 - 170,000

Full time

7 days ago

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Job summary

Seismic Therapeutic, based in Watertown, MA, is seeking a Clinical Trial Manager / Senior Clinical Trial Manager to lead operational planning and execution for early-phase studies. You will manage study workstreams from start-up to closeout, coordinate internal and external partners, and elevate risks with recommendations.

This hands-on role supports the Director, Clinical Operations, involves global timelines, and requires travel.

Qualifications

Bachelor's degree in life sciences, nursing, pharmacy, or related discipline.
5+ years (Clinical Trial Manager) or 8+ years (Senior Clinical Trial Manager) of progressive clinical research experience.
Experience in CRO/vendor management; domestic and international experience is a plus.
Proficiency with clinical systems and tools such as EDC, CTMS, eTMF, IRT/RTSM, Microsoft Excel, PowerPoint, and Word.

Responsibilities

Coordinate day-to-day operational activities for clinical studies with CROs and vendors, tracking scope, timelines, budget, quality standards, and study objectives.
Ensure study plans are developed and maintained with risk/issue logs, enrollment forecasts, and metrics; identify emerging risks and provide recommendations.
Develop, review, and implement protocols, informed consent forms, eCRFs, monitoring and enrollment plans, and study tools.
Coordinate sponsor oversight of monitoring activities, review plans/reports, and follow up site-level findings.
Maintain inspection-ready TMF documentation and ensure cross-functional vendor coordination for investigational product and labs.
Facilitate cross-functional study activities with clear communication and documented actions and decisions.