Neha Shah brings over 16 years of experience in the clinical research and pharmaceutical industry, with deep expertise in global clinical data management and regulatory compliance. She currently serves as Clinical Data Management Lead at ITM in Germany, where she leads end-to-end data management activities across multiple oncology trials, ensuring alignment with international standards and regulatory expectations.
Her background spans a range of therapeutic areas including oncology, infectious diseases, cardiovascular, CNS, and medical devices. Neha has held key roles at organizations such as MorphoSys, Tata Consultancy Services, and Syneos Health, leading data management teams, overseeing external vendors, and driving process improvement initiatives. She has contributed to regulatory submissions (e.g., IND, NDA), CDISC standard implementation, SAE reconciliation, and EDC quality oversight.
Neha holds a bachelor’s degree in pharmacy and an MBA in Healthcare Management. She brings a strong track record in building scalable data strategies, maintaining inspection readiness, and delivering high-quality clinical data across global studies.