Melanie Bright

Strategic clinical operations leader with 20+ years’ experience spanning biopharma, CRO, Diabetes, Obesity and rare disease therapeutic areas. Proven track record building and leading high-performing teams, optimizing clinical trial delivery, and driving operational excellence across complex, global environments. I am passionate about clinical trial work getting crucial medicines into the hands of patients. 

NOVO NORDISK INC | Plainsboro, NC           2007-2025

Associate Director Operations, Rare Disease and Advanced Therapies (2022-2025)

Associate Director, Trial Management 

• Established foundational framework and reporting structure for new therapy area, supporting approximately 50 employees and 3 managers, which enabled streamlined operations, clear accountability, and effective prioritization
• Led cross‑functional clinical operations teams to deliver complex global studies in rare disease and advanced therapies, ensuring adherence to ICH/GCP and organizational quality standards. 
• Partnered with cross‑functional leaders to align program strategy with organizational priorities, contributing to streamlined decision‑making and enhanced portfolio performance 
• Oversaw end‑to‑end trial management activities—including planning, resourcing, and data quality—to support timely and compliant study delivery.
• Drove operational excellence by optimizing processes, mitigating risks, and implementing scalable delivery frameworks that improved study execution outcomes across multiple programs.

CSL Manager, Trial Management (2018-2022)

Led Site Activation Optimization Project workgroup, supported data collection and communications for leadership, and contributed to multiple cross-functional initiatives to enhance clinical trial operations in addition to providing functional leadership

• Oversaw management and development of Clinical Site Lead staff (14 direct reports) in compliance with local SOPs, resourcing and trial deliverables. 
• Ensured transparency and partnership within project teams, providing updates and clarifying expectations in a matrix management structure.

Clinical Site Lead (CSL), Trial Management (2007-2018)

Responsible for operational aspects of managing clinical site performance through coordination and communication with In-House CRAs, Field Based CRAs and the Trial Manager (TM) for assigned trials, within the Trial Management (TM) function. Contributed to relationships positively with internal stakeholders relevant to the planning and execution of clinical trial improvement/innovation projects (e.g., across NACO, CMR, International Operations (IO), HQ R&D, & Commercial)

• Oversaw site performance for the lifecycle of assigned trials (e.g., start-up, recruitment, retention, quality, data entry, etc.), including tracking of trends and reporting of key metrics for up to 6 trials at a time
• Performed activities related to project specific training of regional CRAs regarding the implementation, monitoring, and summarization of clinical trials to ensure adherence to all study related documents, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs

PPD INC| Wilmington, NC                              2000-2007

Clinical Team Manager/Principal Clinical Team Manager/Trial Manager (2003-2007)

Scope of role – team size, revenue accountable for, geography, size of client base, transactions processed, etc.

• Acted as principal liaison between client, PPD, vendors, and investigative sites, ensuring effective communication and project execution. 
• Orchestrated internal and external project team meetings, including representatives from Clinical, Data Management, Biostats, IVRS, and client personnel, to drive study progress and address operational concerns
• Participated in review of Request For Proposals (RPFs), contributed feedback and review on proposals and presented project plans to clients at bid defense meetings.

Senior CRA (2002-2003)

CRA (2000-2002)

Managed and monitored multiple clinical trial sites, mentored junior team members, ensured regulatory compliance, and developed tools and training materials to support high-quality study execution

• Managed sites on global Phase III and IV trials in Endocrinology and Gastrointestinal diseases
• Conducted and documented monitoring visits, reviewed case report forms (CRFs) for accuracy and protocol adherence, safety reporting and resolved discrepancies 
• Collected, reviewed and filed essential regulatory documents 
• Reviewed source documents and Case Report Forms for accuracy, protocol compliance and safety reporting
• Trained and mentored junior CRAs

• Bachelor of Science, Human Nutrition and Foods    Virginia Polytechnic Institute and State University, Blacksburg, VA
• Dietetic Internship, East Carolina University, Greenville, NC