Senior Clinical Trial Manager

Summary

Join Generate:Biomedicines as a Senior Clinical Trial Manager (Sr. CTM) to lead the execution of Phase 3 clinical trials. You will report to the Sr. Director of Late Stage Clinical Operations and manage global, late-stage studies supporting regulatory submissions and product approval. Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, Clinical Supply, and Data Management, and serve as a key contact for CROs, vendors, and clinical sites. This role ensures operational excellence, compliance, and delivery in high-stakes studies. You will independently manage operational execution of Phase 3 global clinical trials and oversee CRO partnerships. Contribute to the development of essential study documentation and lead cross-functional study team meetings.

Requirements

• Bachelor’s degree required; advanced scientific degree preferred
• 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

Responsibilities

• 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

Preferred Qualifications

Experience supporting regulatory submission activities or NDA/BLA-aligned trials is a plus