Clinical Operations Leader
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Seasoned clinical operations leader with 24+ years of experience in the Pharmaceutical, CRO, and Biotech industries, with a strong focus on project management, cross-functional team leadership, and vendor oversight. Proven track record in planning and executing complex clinical documentation workflows, ensuring compliance with regulatory standards (ICH-GCP, FDA), and maintaining audit readiness. Expert in Veeva Vault eTMF and the CDISC
TMF Reference Model, driving process optimization and operational excellence. Skilled in stakeholder management, change control, and risk mitigation to ensure on-time, quality delivery of clinical trial objectives.
Gates MRI – Led TMF operations and innovation projects, including eTMF setup, training, AI integration, and global inspection readiness across studies. Served as TMF SME and cross-functional liaison to ensure compliance with ICH-GCP and FDA requirements.
Coherus BioSciences – Managed Veeva Vault eTMF implementation, quality control, and system oversight. Acted as the primary point of accountability for TMF processes, training staff, and supporting sponsor audits.
Labcorp Drug Development – Oversaw TMF remediation and inspection readiness across North and Latin America. Provided strategic guidance on TMF compliance and drove process improvement initiatives at the enterprise level.
Syneos Health – Advanced from Project Coordinator to Trial Master File Project Manager. Led global eTMF operations, conducted audit readiness activities, mentored junior leads, and partnered with sponsors to ensure TMF alignment and quality.
CTG / IBM-Lenovo – Directed global product development projects and operations in a high-tech environment. Managed cross-functional teams, budgets, and risk mitigation strategies for large-scale initiatives.
Earlier Roles (Schering-Plough, Weatherby Healthcare, The Eleven Agency) – Built foundational expertise in pharmaceutical sales, recruitment, branding, and customer relationship management, consistently exceeding performance targets.
Master of Business Administration/Concentration: Project Management
KELLER GRADUATE SCHOOL OF MANAGEMENT
