Accomplished Clinical Project Manager with a global mindset and over 14 years of expertise in the Pharmaceutical Industry, Biotechnology, R&D Procurement, Compliance, Business Operations, end-to-end Contract Management, Clinical Trial Operations, and processes (Phases I-IV), as well as clinical vendor qualification, oversight, and supplier diversity.
Skilled at leading complex, cross-functional projects, driving strategic initiatives, and delivering innovative business solutions.
Strong analytical and problem-solving abilities, with expertise in stakeholder management, risk mitigation, and process optimization.
Experienced in clinical vendor selection, qualification, vendor management, and third-party risk assessment, ensuring regulatory compliance and operational excellence.
Proficient in financial oversight, budget management, and contract negotiation, delivering cost-effective solutions.
Effective communicator and collaborator, adept at building relationships, influencing decisions, and aligning teams toward shared objectives.
Possesses extensive organizational, analytical, and problem-solving skills, excelling in fast-paced environments with competing priorities and tight deadlines.
Passionate about continuous improvement, innovation, and mission-driven work aligned with organizational values.
15 years relevant experience at biotechnology, pharmaceutical industry with Clinical Development, Clinical Trial Procedures and processes, CRO and Clinical Vendor Selection, Qualification and Oversight, for clinical lab operations
Experience managing Central Laboratory Study startup, Site Management and Core Metrics & KPIs for Ph1-3 Trials
Experience with Vendor Management, Operations and Clinical Oversight
Excellent organizational and problem-solving skills to multi-task in an extremely fast-paced environment with tight timelines and competing priorities
Solid understanding of end to end clinical trial process
Demonstrated effective communication skills with internal and external stakeholders, leadership, and other cross-functional team members
Project management
Budgeting and forecasting
Risk management
Scope management
Cross-functional collaboration
Contract management
International Council for Harmonization (ICH) guidelines,
Good Clinical Practices (GCP),
Annual Health Care Compliance Training
Clinical Trial Process Training
Managed the JRP Resume Library and Training Curricula for the entire Janssen R&D Procurement team, with a focus on audit readiness-related projects, achieving 100% compliance by designing a comprehensive tracking system.
Completed Compliance Wire Training to assign & credit CW training to all JRP employees
JRP Supplier Diversity Team member, managed Diverse & SBA supplier e2e certifications and conducted spend analysis via Tableau, contributing to the growth of J&J R&D’s Credo and small business-related Global Diversity Spend and Supplier Diversity & Inclusion corporate initiative