Senior Clinical Trial Manager

1w1 week ago

ARTBIO

Cambridge, US · Full-time · $175,000 – $225,000

About this role

The Senior Clinical Trial Manager leads day-to-day activities in a clinical trial and supports program strategy in a highly collaborative environment. They manage clinical operations team members, including those at CROs and study vendors. Work with clinical trial sites and internal stakeholders ensures deliverables are on time, within budget, and regulatory compliant.

Drive study startup through feasibility, site selection, and timelines while managing Phase 1 and 2 investigators focused on US sites for protocol compliance. Proactively identify, manage, and mitigate risks with the study team. Serve as cross-functional lead and primary escalation point for trial execution.

Lead cross-functional meetings with Clinical Development, Operations, Data Management, Regulatory, Quality, and Supply Chain. Oversee CROs and vendors for data integrity via review of case report forms, source documents, and medical records. Perform site activities like onsite/remote monitoring, co-monitoring, and training visits.

Contribute to study documentation including protocols, operations manuals, ICFs, CRFs, and data cleaning. Ensure compliance with FDA regulations, ICH GCP, and company SOPs. Limited travel (~25%) to clinical sites supports supervision and monitoring in oncology-focused trials.

Requirements

Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or a related field
5 to 8 years of experience in clinical operations or direct study management in a biotech or pharmaceutical company (Industry Sponsor)
Extensive experience managing US clinical sites, including start-up activities and monitoring
Experience in oncology (preferably in solid tumors); radiopharmaceuticals a plus
Experience overseeing CROs and vendors, maintaining timelines, and overseeing budgets
Experience with clinical data review and data management processes
Strong working knowledge of GCP, ICH, and FDA regulations
Excellent communication, organizational, and leadership skills

Responsibilities

Lead cross-functional meetings with Clinical Development, Clinical Operations, Data Management, regulatory, Quality, and Clinical Supply Chain
Drive study startup activities, including feasibility, site selection, and timelines
Manage activities of Phase 1 and 2 clinical trial investigators with a focus on the US to ensure compliance with the study protocol
Proactively manage, identify, and mitigate risks with the study team
Serve as cross-functional lead for the clinical trial and primary point of contact for execution and escalation
Lead oversight of CROs and vendors to assure integrity of clinical data through review of case report forms, source documents, and medical records
Perform clinical research site activities, including onsite or remote monitoring, co-monitoring, and training visits
Ensure all study documentation and SOPs are maintained according to applicable regulations and industry standards