Job
Description
Location: Pune-Kothrud/Wakad(Offline/Online) Experience: 2-3 yrs Qualification: Graduate/Post Gradu Job Description: Job Summary: We are seeking a highly qualified and experienced Clinical Data Management (CDM) Trainer to deliver a structured and in-depth curriculum covering Clinical Research, Drug Development, GCP-ICH Guidelines, Clinical Data Management, Pharmacovigilance, and Regulatory Affairs. The ideal candidate should have a strong background in clinical research and data management with proven experience in training or academic instruction. Key Responsibilities: Design, update, and deliver training content aligned with the clinical data management curriculum. Conduct engaging classroom and/or online sessions with clear understanding and explanation of: Clinical Research concepts and terminology Drug Development process and phases GCP-ICH E6 compliance and ethical practices Clinical Data Management principles including CRF design, query management, and source data validation Pharmacovigilance protocols including AE reporting and safety management Regulatory frameworks including CFR, CDSCO, ICMR, and CT Rules 2019 Provide real-world examples and case studies to enhance learner understanding. Assess student learning through quizzes, assignments, and interactive discussions. Stay updated with evolving industry guidelines and trends. Offer mentorship and support to trainees preparing for roles in clinical research and data management. Required Qualifications: Education: Master’s degree or higher in Life Sciences, Pharmacy, Clinical Research, Biotechnology, Medicine, or related field. Experience: Minimum 2–3 years of professional experience in Clinical Research, Clinical Data Management, or related domain. Minimum 1 years of teaching/training experience (corporate training or academic instruction preferred). Hands-on experience with regulatory compliance, pharmacovigilance systems, and EDC tools (e.g., Medidata Rave, Oracle Clinical, etc.) is a plus.
