AI in Clinical Data Management Training Program

With Long-Term Industry-Oriented Projects (3,6, & 12 Months LIVE Project Work)

Clinical Data Management Training Program: Basic to Advanced

ADMISSIONS OPEN

BATCH STARTS - 22nd JAN 2026

100% PLACEMENT ASSISTANCE

GET A WORK EXPERIENCE LETTER WITH 6 & 12 MONTHS PROJECT WORK

100% Placement Assistance

Master Clinical Data Management with Artificial Intelligence from fundamentals to real-world, end-to-end AI-driven CDM systems used by Pharma, CROs & Clinical Research Organizations.

Program Overview

The AI in Clinical Data Management Training Program is a job-oriented, hands-on certification designed to train professionals in traditional CDM workflows combined with advanced AI, ML, NLP, and automation techniques used in modern clinical trials.

This program bridges the gap between conventional CDM roles and next-generation AI-enabled clinical data operations, preparing you for high-demand roles across Pharma, Biotech, CROs, and HealthTech companies.

✔ Learn CDM from scratch
✔ Apply AI to real clinical datasets
✔ Work on 3-month, 6-month or 12-month long-term projects
✔ Get 100% Placement Assistance

Program Details:

• Batch Starts: 22nd JAN 2026
• Course Duration: 90 Days + project Work
• Project Duration: 3,6 & 12 Months (Starts after Training Program Completion)
• Get Recording (for revision and in case you miss the class) + LIVE class Access
• Timings: 8:00 - 9:00 PM IST
• Venue: Online
• 100% Placement Assistance by BioTecNika Placement Team

Who Should Enroll?

• Life Science & Biotechnology graduates

• Pharmacy, Clinical Research & Healthcare professionals

• Clinical Data Coordinators / Associates

• Professionals working in clinical trials, PV, regulatory affairs

• Freshers looking to enter CDM with AI skills

• Anyone aiming to future-proof their CDM career

No prior coding or AI background required.

PLACEMENT PROOF

What Makes This Program Unique?

• AI-first Clinical Data Management curriculum

• Real-world EDC tools, MedDRA, CDISC, SDTM exposure

• Use of free & industry-relevant AI tools

• Long-term portfolio-ready projects

• Faculty-led demos + live Q&A

• Career guidance + placement support

COURSE INSTRUCTORS

Bhanu Melvin 
Scientist & Trainer - CDM, PV & RA

Bhanu Melvin, with a strong academic foundation in pharmacy and over a decade of diverse experience across academia, healthcare, regulatory affairs, and corporate training, brings a holistic and agile approach to professional development and organizational excellence. He has successfully trained more than 1,500 individuals, including academic aspirants and industry professionals, in Clinical Research, Pharmacovigilance, Clinical Data Management, Regulatory Affairs, and Clinical SAS Programming. Holding globally recognized certifications in Pharmacovigilance, Lean Six Sigma Black Belt, Clinical Research, Clinical SAS Programming, and ISO 9001:2015 Lead Auditing, he effectively bridges the gap between scientific knowledge, regulatory frameworks, and operational efficiency. Passionate about driving impact, he specializes in designing skill-oriented curricula, strengthening compliance standards, and streamlining clinical workflows to deliver transformative training and strategic solutions tailored to evolving industry needs.

Sushma H
Scientist & Trainer - CDM, PV & RA

Sushma H, an MSc Gold Medalist in Organic Chemistry, has built a strong foundation in scientific research and analytical skills through her academic and professional journey. As a Research Associate at Advarra, she gained hands-on expertise with REDCap for data capture and management, MedDRA coding for standardized adverse event reporting, and CDISC terminologies for regulatory-compliant clinical data submissions, while also developing an in-depth understanding of clinical trial management processes, study workflows, data collection, and quality checks. She further enhanced her career as a Data Scientist at PointCross, working with SDTM standards to assess and analyze various clinical trial phases, generate actionable insights from complex datasets, and support data-driven decision-making throughout the trial lifecycle. Now joining Biotecnika as a Scientific Writer and Trainer, Sushma is set to leverage her research and analytical expertise to create high-quality scientific content and mentor aspiring professionals in the life sciences.

DOWNLOAD BROCHURE

Check Detailed Curriculum & Projects

Detailed Curriculum

Module I – Introduction to Clinical Data Management
Fundamentals of CDM, clinical trial phases and designs, clinical data types, protocol understanding, CDM documentation, trial stakeholders, and revision.

Module II – AI in Clinical Data Management
Basics of AI and ML, intersection of AI with CDM, AI implementation, recent trends, automation, and assessment.

Module III – Regulatory Frameworks and Standards
ICH-GCP, FDA, EMA, GDPR, ISO standards, AI in regulatory compliance, CDMS overview, metadata management, and CDISC standards.

Module IV – Data Integrity and EDC Systems
EDC systems, ALCOA+ principles, data quality metrics, validation and verification, SAS overview, and practical demonstrations.

Module V – CDM Work Processes
Study structures in EDC, data quality management, database concepts, CDISC/SDTM/MedDRA, data cleaning, regulatory adherence, and AI-based demos.

Module VI – EDC Tools and Implementation
REDCap, Medidata Rave, OpenClinica, Veeva Vault, Castor, AI and ML tools in CDM, user roles, permissions, and assessment.

Module VII – Core Data Operations
Source data management, query management, data cleaning, validation, and database lock procedures.

Module VIII – Safety and Timeline Management
SAE reconciliation, safety data management, regulatory updates, data migration, CRO–sponsor coordination, vendor management, and assessment.

Module IX – AI for Risk-Based Monitoring and Patient Safety
AI-driven data standardization and harmonization, RBM, patient safety analytics, MedDRA coding, anomaly detection, and hands-on case studies.

Module X – Hands-on CDM Execution
End-to-end study setup and execution in EDC, CRF design, data entry, query handling, reports, dashboards, audit trails, eSignatures, and mid-term assessment.

Module XI – Mid-Study Adaptation and Innovation
Mid-study changes, decentralized and remote trials, EDC monitoring, eConsent, and recruitment strategies.

Module XII – Advanced CDM and Digital Transformation
AI-assisted data cleaning, automated validation, intelligent query automation, AI in data analysis, operational efficiency, compliance, and challenges.

Module XIII – Professional Roles and Industry Integration
CRC, CRA, Data Manager and Administrator roles, freelancing in CDM, and expert interactions.

Module XIV – Future Trends, Ethics, and Career Path
AI-driven risk prediction, ethical considerations, global career opportunities, roles, salary trends, required skills, resume building, and networking.

Module XV – Project Work
Real-world CDM and AI project execution with extended mentorship.

Long-Term Project Options

🔹 3-Month Projects

Focus on core AI applications in CDM & data quality

Examples:

• AI-based identification of high-risk clinical trial sites

• AI-driven analysis of aging queries

• AI-assisted RBM & data reconciliation

• AI-driven data cleaning & standardization

• AI-powered MedDRA coding & query management

Deliverables:
✔ Cleaned & standardized datasets
✔ AI-generated risk summaries
✔ Project reports & dashboards

🔹 6-Month Projects

Advanced automation, harmonization & compliance-focused projects

Examples:

• Generative AI for CSR & protocol automation

• Audit trail analysis using AI

• Multi-center data harmonization using AI

• AI-powered risk detection systems

• AI-driven clinical data review & query management

Deliverables:
✔ AI pipelines
✔ Risk scoring models
✔ Compliance-ready reports

🔹 12-Month Projects

End-to-end industry-grade AI systems

Examples:

• End-to-End AI Framework for RBM & Patient Safety

• AI-powered mental health risk assessment

• AI diagnosis assistants

• Full data cleaning, harmonization & analytics pipelines

• Ethics & Responsible AI frameworks for clinical data

Deliverables:
✔ Complete AI systems
✔ Dashboards & documentation
✔ Portfolio-ready industry projects

Certification & Outcomes

• Industry-recognized certification

• Hands-on project experience

• Job-ready portfolio

• Exposure to CDISC, SDTM, MedDRA, EDC systems

• Confidence to work in AI-enabled CDM roles

 Career Opportunities After This Program

• Clinical Data Analyst (AI-enabled)

• Clinical Data Coordinator

• Risk-Based Monitoring Analyst

• AI-CDM Specialist

• Clinical Data Quality Analyst

• Clinical Operations Analyst

100% Placement Assistance Includes

• Resume & LinkedIn optimization

• Interview preparation sessions

• Mock interviews

• Job referrals through partner networks

• Continuous placement support until you get placed

Tools & Technologies Covered

• Castor EDC, OpenClinica

• MedDRA, WHO-DD, CDISC, SDTM

• AI & NLP concepts

• Google Sheets Explore, Excel AI

• spaCy, NLP tools

• Free & paid AI platforms used in CDM

Ready to Transform Your CDM Career?

👉 Enroll now and become industry-ready in AI-powered Clinical Data Management.

👉 Limited seats | Hands-on | Project-driven | Career-focused