Job Description

Hands-on clinical trial leader responsible for day-to-day execution of mid to late-stage CKD studies. This role partners closely with cross-functional teams and external vendors to ensure studies are delivered on time, within budget, and with high data quality and compliance standards.

Core Responsibilities

Study Execution

• Co-lead Phase 2-3 CKD study execution from protocol development through CSR
• Support key milestones including FPI, enrollment completion, interim analysis, and database lock
• Lead feasibility assessments and support site selection strategy
• Develop enrollment forecasts and support KOL engagement with Clinical Science

CRO, Vendor & Site Management

• Lead RFP process and vendor selection for CROs and trial partners
• Support contract and budget negotiations
• Provide day-to-day oversight of CROs, vendors, and sites to ensure performance and compliance

Budget Oversight

• Track study budgets and manage vendor spend in partnership with Clinical Operations leadership

Quality & Compliance

• Ensure data integrity and adherence to protocols, SOPs, and ICH-GCP
• Support inspection readiness efforts with Quality Assurance

Operations & Systems

• Help evaluate and implement clinical systems (eTMF, CTMS, RBM, etc.)
• Contribute to SOP development and scalable operational processes

Cross-Functional Collaboration

• Partner with CMC and Clinical Supply Chain to manage drug supply logistics
• Work closely with internal functions to ensure smooth study delivery

Qualifications

Required

• Bachelors degree in scientific or health-related field
• 5–8 years Clinical Operations experience, including 4+ years as a CTM
• Hands-on management of Phase II–III clinical trials
• Knowledge of FDA, EMA, and ICH-GCP guidelines
• Experience with clinical systems (e.g., Medidata Rave, Veeva)
• Experience with study start-up through close-out
• CRO/vendor oversight and clinical trial budget tracking experience
• Strong execution and cross-functional coordination skills
• Comfortable in fast-paced, growth-stage environment
• Excellent communication skills
• Willingness to travel up to ~30%

Preferred

• Global trial experience
• Experience in common disease drug development