Clinical Trial Manager​/Senior Clinical Trial Manager

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Full Time Employee Professional Watertown, Watertown, MA, US

Salary Range: $ To $ Annually

SEISMIC THERAPEUTIC

Clinical Trial Manager / Senior Clinical Trial Manager

About Seismic

Seismic Therapeutic is making a major shift in how immunology therapies are discovered and developed, enabled by machine learning. We have brought together a stellar team of leading immunology drug developers, machine learning innovators and company builders who are charting new drug discovery territory to open better and faster ways to make medicines for patients with immune-driven diseases.

At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient‑centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that.

Job Summary

This is a terrific opportunity for a highly motivated, hands‑on Clinical Trial Manager to join our small, dynamic and high‑performing clinical operations team.

We are adding this position to support the Director, Clinical Operations as Seismic's clinical portfolio grows. In this role, you will support the operational planning and execution of early‑phase clinical studies under the direction of the Director. You will manage defined study activities and work streams from study start‑up through database lock and closeout, coordinate internal and external partners, maintain operational visibility, and
** escalate risks
** with recommendations. The role will initially support our lead clinical program and expand as Seismic's pipeline advances.

This position may be filled at the Clinical Trial Manager or Senior Clinical Trial Manager level, depending on experience.

Key Responsibilities

• Coordinate day‑to‑day operational activities for clinical studies both within Seismic and with CRO and other vendors, including tracking delivery against scope, timelines, budget, quality standards, and study objectives, and promptly
  ** escalate material risks or decisions**.
• Ensure study plans are developed and maintained including risk and issue logs, enrollment forecasts, meeting actions, and operational metrics. Identify emerging risks, investigate options, and provide recommendations to the Director and study team.
• Contribute to and coordinate the development, review, approval, and implementation of protocols and amendments, informed consent forms, eCRFs and completion guidelines, monitoring and enrollment plans, pharmacy and laboratory manuals, study‑specific procedures, and site tools.
• Coordinate sponsor oversight of monitoring activities, including review of monitoring plans and reports, trend analysis, co‑monitoring or oversight visits as appropriate, and follow‑up of site‑level findings. Review data and operational quality indicators, including protocol deviations, query trends, and data‑cleaning backlogs.
• Maintain complete, current, and inspection‑ready documentation for assigned studies, including TMF oversight and follow‑up of filing gaps.
• Ensure coordination of other key cross‑functional vendors for investigational product and ancillary supply (in collaboration with CMC and Quality) and bioanalytical and exploratory laboratory testing (in collaboration with Translational Sciences)
• Coordinate cross‑functional study activities and maintain clear communication including facilitating meeting agendas and minutes, ensuring documentation of decisions and actions, and clear next steps to internal and…