Senior Clinical Trial Manager, Early-Phase Immunology

Seismic Tx; Northern (KY); 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

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.