Ajay Bhasale
Senior Director, Data Management ✨
Transforming biopharmaceutical research through innovative data strategies and leadership in clinical data management.
Transforming biopharmaceutical research through innovative data strategies and leadership in clinical data management.
Seasoned pharmaceutical executive with extensive experience in clinical data management, analytics and programming within the biopharmaceutical industry. Proven track record of leading cross-functional teams to deliver high-quality data management solutions that accelerate drug development and ensure regulatory compliance.
My superpower? Making complex data concepts accessible to everyone from scientists to CEOs. I am passionate about data standards, process optimization, and mentoring the next generation of data professionals.
Therapeutic Areas
Clinical Trials
Team Members
Recognitions
The skills I have mastered to fight the forces of messy data and inefficient processes
Building and mentoring high-performing global data management teams, fostering collaboration across functions, and creating a culture of continuous improvement and innovation.
Developing comprehensive data strategies aligned with clinical development objectives, ensuring data quality, integrity, and regulatory compliance throughout the drug development lifecycle.
Ensuring adherence to FDA, EMA, ICH-GCP, and other regulatory requirements, with expertise in CDISC standards (C-DASH, SDTM, ADaM, ODM), 21 CFR Part 11, and data privacy regulations.
Deep understanding of oncology, rare diseases, immunology, inflammatory pain, hepatology and cardiovascular therapeutics, with ability to tailor data strategies to specific therapeutic area requirements.
Implementing lean methodologies and digital solutions to streamline clinical data processes, reduce cycle times, and improve operational efficiency without compromising quality.
Leveraging advanced analytics, machine learning, gen AI, and visualization techniques to derive actionable insights from clinical trial data, supporting evidence-based decision making.
Want to discuss how I can help with your data challenges? Drop me a message!
I am always excited to connect with fellow data enthusiasts, potential collaborators, or anyone interested in advancing pharmaceutical data science.
(650) 477-0119
San Mateo, California, USA