Provided expert consultation to stakeholders from leading pharmaceutical and biotechnology firms on data standardization practices. Resolved complex data standardization challenges, ensuring compliance with industry standards. Mentored team members and study groups.

Directed full lifecycle of SDTM data preparation and submission for multiple clinical trials, ensuring compliance with FDA and PMDA requirements and securing full data acceptance. Acted as the primary data standards liaison during authority interactions, including briefing books, meetings, and audits. Engaged with mid-senior level management to strategize on data standards and submission approaches. Spearheaded the standardization efforts for specialized vendor and biomarker data across studies. Provided coaching to clinical study teams and vendors on data standards adherence and readiness for submission. 

• Successfully led data submissions for significant projects to both FDA and PMDA, including conducting data consultation meetings in Tokyo and completing authority inspections.
• Represented the company in critical regulatory authority interactions, influencing positive outcomes and establishing a strong presence in the field.
• Negotiated scope and pricings for the data standards function in bid defense meetings, effectively communicating expertise and contributing to business development.
• Provided expert coaching to clinical study teams and vendors, significantly improving compliance with data standards and submission readiness.

Optimized processes for data standardization, including CRO and external vendor oversight, thereby significantly enhancing data standards compliance for SDTM data. Orchestrated cross-functional collaboration with Data Management, Biostatistics, Medical, Regulatory, and Biomarker teams to guarantee seamless SDTM data execution and prepare clinical trial teams for submission. Formulated and implemented guidelines, working instructions, and SOPs to govern SDTM data processes effectively. 

• Enhanced the quality of data received from CROs by implementing robust oversight processes.
• Facilitated the seamless execution of clinical trial data, ensuring submission readiness and compliance with regulatory standards.
• Developed and managed a critical data standard library, centralizing resources for SDTM data management.
• Spearheaded the creation of comprehensive training materials and programs, enhancing the proficiency of teams worldwide in CDISC standards.