We seek professionals who combine strong Pharma/Lifesciences domain expertise with an AI-ready mindset, leveraging AI, GenAI, Data, and Digital Technologies to transform business processes, accelerate outcomes, and unlock new opportunities for innovation.
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.
