Senior Clinical Trial Manager

Benefits

Qualifications

• •4+ years of clinical trial management experience, with at least 2 years in Phase 3 trials at a sponsor or CRO
• •Proven expertise in global trial execution, CRO oversight, and clinical vendor management is required
• •Experience in various therapeutic areas (including oncology, immunology, and respiratory, if possible)
• •Strong knowledge of GCP, ICH guidelines, and FDA/EMA regulatory expectations for pivotal studies
• •Excellent organizational, problem-solving, and communication skills with ability to manage complex workflows and stakeholder expectations
• •Comfortable with limited travel (up to 30%) to support global study needs, site visits, or vendor engagement
• •Ability to travel up to 30% of the time, both domestic and international
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Responsibilities

• •Generate Biomedicines is seeking an experienced and collaborative Senior Clinical Trial Manager (Sr
• •CTM) to lead the execution of Phase 3 clinical trials within our Clinical Development team
• •This role will report to the Sr
• •Director of Late Stage Clinical Operations and be responsible for managing global, late-stage studies intended to support regulatory submissions and eventual product approval
• •CTM will work cross-functionally across Clinical Development, Regulatory Affairs, Clinical Supply, and Data Management, while serving as a key point of contact for CROs, vendors, and clinical sites
• •This is a critical role for ensuring operational excellence, compliance, and delivery in high-stakes studies where quality and precision are paramount
• •Independently manage the operational execution of Phase 3 global clinical trials, including startup, conduct, and closeout activities
• •Serve as the primary clinical operations lead overseeing CRO partnerships, ensuring vendor accountability and performance against timelines and budgets
• •Drive global site activation, enrollment tracking, and clinical data flow oversight, ensuring alignment with regulatory requirements and strategic milestones
• •Oversee and contribute to the development of essential study documentation including protocols, ICFs, operations manuals, and investigator-facing materials
• •Lead cross-functional study team meetings and monitor progress against critical path timelines and KPIs
• •Actively participate in inspection readiness planning, including TMF health oversight, audit support, and document quality control
• •Ensure real-time issue escalation, risk mitigation, and resolution of site, CRO, or operational challenges
• •Collaborate with regulatory and quality teams to ensure trial execution aligns with global GCP, FDA, EMA, and ICH standards
• •Lead vendor and budget management for assigned studies, including contract execution and ongoing financial tracking
• •Mentor junior clinical team members and contribute to SOP development and process optimization for late-stage trial conduct
• •13 more items(s)