Clinical Data Management Trainer

Aspire Techsoft; Pune District; On-site; INR 400,000 - 800,000; Full time

Job summary

Aspire Techsoft in Pune district, Maharashtra, is seeking an experienced Clinical Data Management trainer to deliver practical training on CDM topics and EDC systems. You will prepare materials, assess learners, and conduct online and classroom sessions for freshers and working professionals.

The role focuses on real-world trial data management workflows, enabling learners to understand regulatory requirements and CDISC standards while advancing their teaching and communication skills.

Qualifications

• Graduate/Postgraduate in Life Sciences, Pharmacy, Biotechnology, Nursing, Clinical Research, or related discipline.
• Hands-on training/teaching experience preferred.
• Minimum 2+ years of experience in Clinical Data Management.
• Experience with CDISC standards and medical coding is an added advantage.

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.

Skills

CDM processes

EDC systems

CRF/eCRF

MedDRA/WHODrug

CDISC standards

GCP/regulatory

Teaching skills

Industry experience

Communication skills

Education

Graduate/Postgraduate in Life Sciences, Pharmacy, Biotechnology, Nursing, Clinical Research, or related discipline

Tools

EDC software

CDM tools

Job description

• 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.