Clinical Trial Manager / Senior Clinical Trial Manager

Seismic Tx; Massachusetts; Hybrid; USD 130,000 - 170,000; Full time

Job summary

Seismic Therapeutic in Watertown, MA is seeking a Clinical Trial Manager or Senior Clinical Trial Manager to join our growing clinical operations team. This hands-on role supports the Director, Clinical Operations and oversees study activities from startup to closeout, coordinating internal and external partners and elevating risks with recommendations.

You will manage early-phase studies, ensure plans, documentation, and TMF readiness, and contribute to SOPs and vendor governance.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or related field; advanced degree a plus.
• 5+ years (CT Manager) or 8+ years (Senior CT Manager) of progressive clinical research experience.
• Experience coordinating or managing Phase 1 and/or Phase 2 trials; biotech/pharma/CRO background acceptable.
• Experience in CRO/vendor management; domestic and international experience a plus.
• Working knowledge of ICH-GCP, FDA/global regulatory requirements, SOPs, and inspection-readiness.

Responsibilities

• Coordinate day-to-day operational activities for clinical studies with CROs and vendors; track scope, timelines, budget, quality, and study objectives; elevate risks.
• Develop and maintain study plans including risk/issue logs, enrollment forecasts, and operational metrics; advise Director and study team.
• Contribute to development, approval, and implementation of protocols, ICFs, eCRFs, monitoring plans, and site tooling.
• Coordinate sponsor oversight of monitoring activities; review plans, trend analysis, and site-level findings; ensure data quality.
• Maintain inspection-ready TMF documentation and study files; manage filing gaps.
• Coordinate cross-functional study activities and ensure clear communication with stakeholders; facilitate agendas and minutes.
• Support SOPs, templates, vendor governance practices, systems, and lessons learned.

Skills

Clinical trial management

Cross-functional collaboration

Regulatory knowledge (ICH-GCP)

Documentation and risk management

Global travel readiness

Education

Bachelor's degree in life sciences, nursing, pharmacy, or related

Tools

EDC

CTMS

eTMF

IRT/RTSM

MS Excel

PowerPoint

Word

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Trial Manager / Senior Clinical Trial Manager

Full Time Employee Professional Watertown, Watertown, MA, US

Salary Range: $130,000.00 To $170,000.00 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 workstreams from study start-up through database lock and closeout, coordinate internal and external partners, maintain operational visibility, and elevate 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 elevate 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.

Required Qualifications

• 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 elevate 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.

Preferred Experience

• 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.
• Ownership and accountability for assigned deliverables, with urgency, attention to detail, and follow-through required to complete them reliably.
• Collaborative teamwork that builds trust across disciplines, invites input, and supports timely, well-informed decisions.
• Operational discipline, including working independently, accurate tracking, clear documentation, proactive follow-up, and thoughtful use of data and risk-based thinking.
• Adaptability and learning agility in the face of ambiguity, changing priorities, and the hands-on work required to support an emerging pipeline.
• Patient focus, connecting operational decisions to participant safety, data integrity, and the potential impact of Seismic's medicines for patients.

Other

This role is based in Watertown, Massachusetts, with in-office expectations consistent with Seismic's company policies and business needs. Domestic and international travel approximately 20–30%, based on study needs.

The annual base salary range for this position is $130,000 - $170,000 (depending on experience and level).

Seismic Therapeutic is an equal opportunity employer. We welcome applicants of every background and make employment decisions without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran status, pregnancy, genetic information, or any other status protected by federal, state, or local law. If you need an accommodation during the application or interview process, please let us know.