Sr. Manager, Clinical Operations

Overview

In this role you lead global clinical trial planning and execution from start-up to closeout, guiding cross-functional teams to meet timelines, budgets, and regulatory standards. You will manage trial delivery, vendor relationships, and quality oversight, driving risk mitigation and alignment across stakeholders. Your work supports development program goals through process improvement and inspection readiness, helping bring RNAi therapeutics to patients. This position offers a meaningful impact on trial success and cross-functional collaboration.

Responsibilities

• Lead cross-functional trial teams to develop and execute study operational plans and end-to-end trial execution
• Own trial-level delivery including timelines, budget, quality oversight, milestones, and deliverables
• Oversee CRO and vendor selection, onboarding, contracting, budget management, and performance monitoring
• Identify and mitigate operational risks to meet study goals and regulatory requirements
• Ensure trial operations comply with global regulations and internal procedures; support inspections and QA audits
• Maintain trial readiness in collaboration with R&D Quality
• Contribute to continuous improvement for efficiency, quality, and cross-functional collaboration
• Mentor onboarding and development of Study Management staff
• Interface with key stakeholders across Finance, Program Management, Vendor Management, Safety, Quality, Data Management, Clinical Research, Regulatory, Medical Affairs; may liaison between groups
• Provide budget variance analysis and alert Finance to over/under expenditures
• Prepare operational updates and risk recommendations for governance and leadership forums
• Travel approximately 10% (flexible)

Key requirements

• BS/BA degree
• 7+ years of clinical research experience in CRO, biotech, or pharmaceutical company
• 3–5 years leading end-to-end global clinical trials; experience in Phase 3 registrational trials
• Experience leading global trials outsourced to a CRO; manage execution of trials
• Strong decision-making, analytical and financial management skills
• Proven leadership in cross-functional teams within global matrix organizations
• Experience mentoring/coaching others
• Excellent organizational, prioritization, problem-solving, and communication skills
• Proficiency with MS Office Suite (Excel, Word, PowerPoint) and MS Project

• strong leadership and influence
• cross-functional collaboration
• mentoring and coaching
• budget management and variance analysis
• vendor management and contract oversight
• GCP/compliance knowledge

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