Teresa Montes

Clinical Practice Lead providing trusted guidance in navigating complex industry challenges.

• Engaged for expert guidance and strategic recommendations, investment roadmap development, delivery of critical projects, addressing mergers/acquisitions, and resolving critical regulatory findings for small to large global pharmaceutical partners.
• Expert in Veeva systems, integrations, and optimization of clinical environment to streamline operations.
• Migration leader for multiple small to very large Veeva CTMS, TMF, and Study Start-up migrations, from strategy through delivery. Consultant for Veeva Payments migration.
• Delivered impactful technology change through a holistic approach: identifying areas of system and process improvements, implementing Veeva systems, managing system integrations, and coordinating business operational dependencies to maintain GxP compliance.
• Developed training plans, created training programs, and educated teams on goals and skills to facilitate employees achieve success; provided mentoring for full adoption of skills.

Senior clinical IT consultant delivering increased client satisfaction by providing tailored consulting services and effective problem-solving strategies.

• Developed clinical operations innovation opportunity portfolio for a major biotech, based on the end-to-end clinical process and AI/ML opportunities. Clinical lead for AI enabled site selection application.
• Delivered ground-breaking approach with the implementation of clinical solutions, including first in industry capability to link clinical partner organizations to internal TMF, enabling greater accountability and quality.
• Addressed critical client CAPA responses including a 3 million document migration from FirstDoc to Veeva.
• Designed senior staff dashboards for managing divisions within a major generics pharmaceutical manufacturer.
• Led a global supply chain temperature management system replacement impacting logistics, warehouse operations, and third-party logistics teams.

Engaged IT and business partners in defining objectives, planning budget and portfolio, managing programs, and delivering successful key business changes.

• Established and oversaw IT budget plans and financial account allocations.
• Initiated and launched program for Veeva eTMF implementation, delivery of consolidated investigator portals, third-party IT account management, and integrated learning systems
• Special project lead for critical migrations to address critical MHRA findings.
• Co-lead for continuity of operations project to seamlessly support restructuring.
• Leader for 5-year strategic plan development for clinical operations and clinical data management.
• Managed $10M patient data restructuring resulting from merger activity.
• Led risk and probability solution development of pre-clinical assets.
• Launched and led the Business Analysis Center of Excellence
• Designed partner sourcing program for PM and BA staffing, assuring availability of trained, high-quality project staffing governed by a rate card.