Clinical Trial Manager / Senior Clinical Trial Manager

Seismic Therapeutic Inc•Watertown, MA

1d•$130,000 - $170,000•Onsite

About The Position

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. 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 workstreams 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.

Requirements

Bachelor's degree in life sciences, nursing, pharmacy, or a related discipline; advanced degree is a plus.
5+ years (Clinical Trial Manager) or 8+ years (Senior Clinical Trial Manager) of progressive clinical research experience, including experience coordinating or managing clinical study activities in Phase 1 and/or Phase 2 trials. Experience in a biotechnology, pharmaceutical, or CRO setting is acceptable; sponsor-side and global trial experience is a plus.
Experience in CRO/Vendor Management; domestic and international experience is a plus.
Demonstrated ability to manage assigned study workstreams, maintain timelines and trackers, coordinate cross-functional deliverables, and escalate risks and decisions appropriately.
Working knowledge of ICH-GCP, applicable FDA and global regulatory requirements, clinical trial SOPs, and inspection-readiness expectations.
Proficiency with clinical systems and tools such as EDC, CTMS, eTMF, IRT/RTSM, Microsoft Excel, PowerPoint, and Word.
Ability to travel domestically and internationally if necessary.
Ability to work across global time zones (including APAC).
Excellent written and verbal communication skills, strong organization and follow-through, sound judgment, and the ability to communicate issues and recommendations clearly.

Nice To Haves

Early-stage immunology, autoimmune, inflammatory, allergy, or other biomarker-rich clinical development experience.
Experience with biologics and early-phase studies; exposure to first-in-human, first-in-patient, adaptive or basket study designs, or global study execution is a plus.
Experience performing clinical site monitoring visits, including remote visits.
Experience working in a venture-backed biotechnology company or another lean environment where team members combine strategic thinking with hands-on execution.
Experience supporting regulatory or ethics submissions, safety review committee logistics, and cross-functional clinical development activities.

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 external stakeholders.
Support implementation of Clinical Operations SOPs, templates, vendor governance practices, systems, and lessons learned. Provide practical feedback based on assigned-study experience to help establish Seismic's clinical operations capabilities.