Location: Pune Experience: 2+ years Qualification: Graduate/Postgraduat

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 prospects.

Share practical knowledge of EDC systems and clinical data management tools.

Required Skills:

Robust 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.

Positive 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.

📌 Clinical Data Management Trainer Freelance/part Time Pune
🏢 Aspire Techsoft
📍 Pune