Senior Clinical Trial Manager

Key Responsibilities

• Lead the planning, set-up, execution, and close-out of Phase I-III clinical trials.
• Select and manage CROs, central labs, and other third-party vendors, ensuring all deliverables meet quality standards.
• Develop, manage, and track study budgets and timelines; ensuring adherence to financial and operational targets.
• Collaborate with Clinical Development to draft and finalize study protocols, Informed Consent Forms (ICFs), and other key study documents.
• Proactively identify potential study risks (e.g., slow enrollment, data quality issues) and implement mitigation and corrective action plans.
• Ensure "inspection-ready" Trial Master Files (TMF) and compliance with ICH GCP and regulations.
• Lead or participate in study team meetings and cross-functional working groups as needed to support clinical trial activities.

Qualifications & Skills

• Bachelor’s degree (BS/BA) in a life science or related field
• 7–10+ years of clinical operations experience, including leadership of global Phase II/III trials
• Exceptional verbal and written skills for presenting study updates to executive leadership
• Ability to work independently and collaboratively in a fast-paced environment
• Strong project management and organizational skills, demonstrating ability to get answers and solve problems with a “get it done attitude”
• Proven vendor and CRO management skills
• Strong knowledge of ICH-GCP, FDA, EMA, and other relevant regulations
• Experience managing global, multi-center studies
• Therapeutic experience in rare diseases and/or CNS (strongly preferred)

Benefits

Nura Bio offers a comprehensive and generous benefits package, including medical, dental, and vision insurance, life and disability insurance, health savings and flexible spending accounts (including dependent care), a 401(k) plan, and highly attractive stock options.