James Hwe

About James Hwe

Program & Project Management | Clinical Trial Leadership | Clinical DevelopmentProject management leader with a proven track record in leading global clinical trials, driving strategic initiatives, and optimizing operations in the pharmaceutical and biotech industries. Adept at managing client relationships, ensuring regulatory compliance, and leading high-performing teams from start-up to close-outCore Competencies & ExpertiseClinical Trial Management – Oversight and leadership of multi-phase global clinical programs, ensuring compliance with ICH-GCP, FDA, and EMA regulations. Strategic Planning & Execution – Aligned operational goals with corporate objectives, optimizing processes to enhance efficiency and profitability. Stakeholder & Client Relations – Primary liaison for pharmaceutical sponsors and CRO at project level and driving new business growth Financial & Budget Oversight – Managed financials of clinical projects, ensuring 100% adherence to budget and financial forecasts. Regulatory & Compliance Excellence – Ensured adherence to SOPs, GCP guidelines, and risk-based quality management frameworks. Cross-Functional Leadership – Led and mentored teams of associate project managers, and clinical trial professionals to deliver high-impact projects. Risk Mitigation & Problem Solving – Implemented proactive risk management strategies and maintain audit readinessIndustry Expertise & Therapeutic AreasOncology (Solid & Hematological Tumors)| Cardiology (Heart Failure & Dyslipidemia)| Rheumatology (Systemic Lupus Erythematosus)| Dermatology (Psoriasis)| Rare Disease (Duchenne Muscular Dystrophy, Classic Galactosemia, Severe Combined Immunodeficiency)| Gastrointestinal (Crohn\'s Disease)SystemsSmartsheets | Planisware | VeevaVault | CTMS | Medidata RAVE

Experience

1. Senior Project Leader

   Parexel

   Jun 2022 — Present

   Created and maintained detailed clinical trial project timelines, study startup schedules, and scenario-based planning models in Planisware and Smartsheets• Partnered closely with Functional Leaders to ensure clinical trial plans have accurate information and milestones, deliverables, and dependencies are aligned across study teams• Led implementation of strategic, process, and team improvement and change initiatives cross-functionally• Developed and maintained a formal project plan or co-develop program level guidance / manuals with all key milestones, budgets, and resources assigned to specific tasks and outcomes• Defined metrics for reporting performance against plan. Ensured that all standard project systems and tools are set up correctly and functioning appropriately • Implemented operational strategy as defined in the project plan and updated plan to ensure desired results• Established quality standards for the project (or program) that drive individual and team commitment to quality. Monitored quality of deliverables and implement corrective and preventative action as needed • Served as primary liaison at a study level and responsible for client communication ensuring high client satisfaction. Established effective channels and standards of communication among all key stakeholders that supported timely and efficient execution• Managed the project according to budget with revenue recognition and forecasting, including resource management, pass-through management (review, regular reconciliation and forecasting) and managing Change in Scope in collaboration with the Project Specialist, the Client Contract Manager, the Project Financial Business Partner and functional leaders. Handle all project invoicing activities• Led internal and external project review meetings. Ensuring relevant project (or program) specific training is developed and followed• Provided SOP review and lead or contribute to other organizational initiatives

Education

• Śląska Akademia Medyczna w Katowicach

  Doctor of Medicine (MD), Medicine

  2004 — 2012

• Harvard Medical School

  Other; HMX Fundamentals/Pro online certificate program - Immunology - Immuno-oncology