Clinical Data Management Trainer

• Deliver training on Clinical Data Management topics including:
• Introduction to Clinical Research Clinical Data Management
• Clinical Trial Data Flow Data Management Processes
• Clinical Data Management (CDM) Principles Best Practices
• EDC (Electronic Data Capture) Systems
• CRF/eCRF Design Development
• Data Entry Data Validation
• Edit Checks Query Management
• Medical Coding - MedDRA WHODrug
• Data Cleaning Data Reconciliation
• SAE/AE Data Review and Reconciliation
• Database Lock Data Finalization
• Clinical Data Review
• Data Management Plan (DMP)
• Data Validation Plan (DVP)
• CDISC Standards - CDASH, SDTM ADaM
• Clinical Data Management Guidelines Regulatory Requirements
• GCP and applicable regulatory guidelines
• Practical CDM case studies and real-world scenarios

Key Responsibilities:

• Conduct practical training sessions, case studies, and hands-on exercises.
• Prepare training materials, assignments, assessments, and mock tests.
• Train freshers and working professionals in Clinical Data Management.
• Explain real-world clinical trial data management processes and workflows.
• Evaluate learner performance and provide constructive feedback.
• Conduct online and classroom training sessions as per the schedule.
• Guide learners on industry practices, documentation, and CDM career opportunities.
• Share practical knowledge of EDC systems and clinical data management tools.

Required Skills:

• Strong knowledge of Clinical Data Management processes and clinical trial workflows.
• Good understanding of EDC systems and clinical databases.
• Knowledge of CRF/eCRF, edit checks, query management, data cleaning, and database lock.
• Familiarity with MedDRA, WHODrug, and CDISC standards preferred.
• Understanding of GCP and clinical research regulatory requirements.
• Good communication, presentation, and teaching skills.
• Ability to train both freshers and working professionals.
• Practical industry experience in Clinical Data Management preferred.
• Qualification:
• Graduate/Postgraduate in Life Sciences, Pharmacy, Biotechnology, Nursing, Clinical Research, or related discipline.

Experience Required:

• Minimum 2+ years of experience in Clinical Data Management.
• Prior training/teaching experience preferred.
• Hands-on experience with EDC/CDM tools preferred.
• Experience with CDISC standards and medical coding is an added advantage.

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