Subject Matter Expert - Clinical

Responsibilities:

• Lead domain guidance across Clinical Data Management, RBQM, and Intelligent Clinical Trials.
• Translate complex clinical requirements into AI/data-driven solutions in collaboration with data science, data engineering and technology teams.
• Drive the integration of AI in protocol design, site selection, patient recruitment, and outcome prediction.
• Define and implement RBQM frameworks using data-driven models
• Support the development and deployment of AI-powered chatbots to enhance patient communication, consent management, and site support.
• Identify opportunities to use NLP, machine learning, and predictive analytics in trial operations and monitoring.
• Contribute to solutioning, proposal development, and client presentations from a domain perspective.
• Mentor internal teams on current clinical trends and technologies.
• Advice on implementation and optimization of Clinical Platforms/ Clinical Technologies like Veeva Vault Clinical Suite, Metadata, Oracle Clinical etc.

Required Skills:

• Solid understanding of RBQM methodologies and metrics.
• Proven experience in leveraging AI/ML and advanced analytics in clinical trials – including tools for protocol simulation, predictive modeling, and data harmonization.
• Understanding how chatbots and conversational AI can be used for patient follow-up, FAQs, data collection, and engagement during trials.
• Familiarity with CDISC standards (SDTM, ADaM) and regulatory requirements (ICH-GCP, FDA, EMA).
• Strong interpersonal and communication skills to work with cross-functional teams and client stakeholders.

Preferred Qualifications:

• Experience with platforms like Medidata, Oracle Clinical, SAS, or AI frameworks in healthcare.
• Exposure to chatbot development platforms (e.g., Dialogflow, Microsoft Bot Framework) is a plus.
• Knowledge of FAIR data principles and real-world evidence (RWE) integration.
• Previous experience working with pharma sponsors, CROs, or regulatory bodies.