Role Overview:

We are seeking a dynamic Clinical Data Management & Regulatory Affairs professional to develop and deliver training programs for students and professionals. The trainer will be responsible not just for teaching, but also for designing complete course curricula, delivering interactive classes, and creating engaging learning materials. The goal is to prepare students for real-world industry roles in Clinical Data Management and Regulatory affairs, with a robust understanding of regulatory and compliance frameworks.

Key Responsibilities:

Develop and update comprehensive course content, including PowerPoint presentations, assessments, interactive quiz and assignments for biotech, pharmaceuticals, medical devices, clinical research and chemical industries and ensure the course aligns with current industry standards and best practices.

Deliver interactive online classes and engaging recorded sessions on regulatory affairs & CDM to students and professionals.
Create content for YouTube shorts & videos, reference articles, reading material, eBooks,



and participate in webinars and workshops as required.
Mentor students during project work and guide them in applying regulatory and CDM knowledge to real-life scenarios.
Stay updated with industry trends, tools (e.g., Medidata Rave, OpenClinica, Veeva Vault, AI tools), and global regulatory guidelines (US FDA, EMA, CDSCO, ICH, WHO, etc.).
Provide virtual hands-on training using simulations, case studies, and freely available tools/templates relevant to CDM & regulatory affairs ensuring hands-on learning and real-world exposure.
Collaborate with internal teams for continuous improvement in training delivery and content quality.
Mentor students on career pathways in Regulatory Affairs & CDM.
Provide support through doubt-clearing sessions and career guidance.
Assess student performance through quizzes, projects, and exams, and provide constructive feedback.

Qualifications & Experience:

Essential:

Master’s deg

📌 Clinical Data Management (Bengaluru)
🏢 BioTecNika
📍 Bengaluru