Clinical Data Management Training Program: Basic to Advanced With Hands-on Experience & LIVE Project
Clinical Data Management Training Program: Basic to Advanced
Fast-Track Your Career in Clinical Data Management With Expert-Led Training, Hands-On Experience, and Live Projects
ADMISSIONS OPEN
BATCH STARTS - 10th MARCH 2025
If you’re aiming to break into or advance within the field of Clinical Data Management (CDM), this exclusive program is your gateway. Designed to take you from foundational knowledge to advanced skills, this course offers hands-on training and real-world project experience. By the end, you’ll have the technical knowledge and practical skills needed to excel in a highly competitive and rewarding industry.
Program Details:
- Batch Starts: 10th March 2025
- Course Level: Basic (30 Days), Intermediate (60 days), Advanced With LIVE project (90 Days)
- Get Recording (for revision and in case you miss the class) + LIVE class Access
- Timings: 7:00 - 8:00 PM IST
- Venue: Online
- 100% Placement Assistance by BioTecNika Placement Team
Flexible Learning Options to Match Your Career Goals
- 30-Day Basic Program: The first 30 days of the Clinical Data Management (CDM) training module lay a strong foundation for aspiring CDM professionals. Week 1 introduces the fundamentals of CDM, covering its scope, roles, and regulatory frameworks like ICH GCP and GDPR. Week 2 delves into data standards such as CDASH and SDTM, along with tools like EDC systems and CDMS, focusing on data integrity and quality metrics. Week 3 transitions to Veeva Vault basics, highlighting its architecture, module configuration, and study data flow. By the end of this phase, participants gain a clear understanding of CDM's foundational principles, tools, and career pathways.
- 60-Day Intermediate Program: The next 30 days focus on specialized training and hands-on application. Weeks 4 and 5 explore advanced Veeva Vault functionalities, including CRF design, query management, data accuracy, automation, and compliance monitoring. Week 6 emphasizes critical CDM processes like data cleaning, safety data management, and stakeholder communication. Week 7 introduces real-world case studies, preparing participants to manage practical challenges such as data discrepancies and mid-study updates. By Day 60, trainees acquire advanced knowledge and practical skills in using Veeva Vault for efficient clinical data management and handling industry-relevant scenarios.
- 90-Day Advanced Program: The final phase emphasizes practical application, industry trends, and career readiness. Weeks 8 and 9 offer intensive hands-on practice, mock evaluations, and exposure to emerging CDM trends such as AI, ML, and decentralized trials. Soft skills like communication and problem-solving are integrated into the curriculum. Week 10 prepares participants for certifications, job interviews, and networking in the CDM industry while also exploring career paths beyond CDM. Weeks 11 and 12 focus on project work, enabling trainees to manage comprehensive CDM studies using Veeva Vault. The program concludes with project presentations and feedback, ensuring participants are well-prepared for industry roles.
Project Opportunities
Megha Walishettar
Clinical Data Management Scientist at Biotecnika
Worked at TCS, IQVIA, and WIPRO
A highly accomplished Clinical Data Manager with over seven years of experience, having successfully led data management activities for more than 20 clinical trials across Wipro, TCS, and IQVIA. Known for ensuring robust production processes and maintaining strict compliance with regulatory guidelines, resulting in zero audit findings across all projects.
Demonstrates expertise in vendor quality monitoring, conducting regular assessments to enhance overall data integrity and reliability throughout the project lifecycle. Possesses in-depth knowledge and hands-on experience in Medidata Rave and has effectively managed end-to-end data management activities for Phase I, II, and III therapeutic and medical device studies. A results-driven professional, contributing to the success of clinical trials through strategic leadership and meticulous attention to regulatory compliance.
Who Should Join?
This course is ideal for:
- Aspiring Clinical Data Managers seeking foundational to advanced knowledge in CDM
- Clinical Research Professionals looking to specialize in data management
- Students and professionals in Biotechnology, Life Sciences, and Health Informatics aiming to enter the clinical data field.
What You'll Learn In This Training Program?
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In-Depth Knowledge of Clinical Data Management
Starting with foundational principles, you’ll learn the lifecycle of clinical data, regulatory guidelines, privacy standards, data quality, and cleaning methods. You’ll gain a well-rounded understanding of CDM from start to finish. -
Advanced Data Management Techniques
As you progress, you’ll learn query management, data validation, coding systems, and data analysis—skills that are crucial in high-level CDM roles. -
Practical Expertise with EDC Systems
Hands-on sessions will walk you through essential EDC (Electronic Data Capture) systems, data security protocols, audit trails, and data cleaning practices. -
Familiarity with Industry Standards and Compliance
Through modules on regulatory compliance, CDISC, SDTM, and ADaM standards, you’ll understand the critical industry regulations that govern CDM, giving you the knowledge required for regulated environments. -
REDCap Project Experience
The REDCap project gives you hands-on experience in designing and developing electronic case report forms (eCRFs), annotating CRFs, and understanding the intricacies of data collection, annotation, and compliance.
Benefits of Learning Clinical Data Management (CDM)
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Growing Demand for CDM Professionals
Clinical research is expanding rapidly, and CDM experts are in high demand across biotech, pharmaceutical, and healthcare industries. -
Diverse Career Opportunities
Mastering CDM opens doors to a variety of roles in clinical trials, data analysis, regulatory compliance, and project management. -
Industry-Relevant Skill Set
Gain expertise in critical CDM processes such as eCRF design, regulatory compliance, data standards, query management, and data validation, all of which are essential in today’s clinical research landscape. -
Competitive Advantage
With hands-on experience and real-world project training, this course sets you apart from other candidates, giving you a solid edge in job applications. -
Foundational Knowledge in Compliance Standards
CDM knowledge equips you with an understanding of compliance with global standards (CDISC, SDTM, ICH-GCP), making you a valuable asset in regulated clinical environments. -
Long-Term Career Growth
CDM roles often lead to high-impact positions with opportunities for advancement in clinical research, data analysis, project management, and compliance. -
Versatile Skill Application
The skills learned in CDM are transferable across various roles within clinical trials, from data management to biostatistics, expanding your career options.
Benefits of Enrolling
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Hands-On Learning: Gain practical experience that you can directly apply in the workplace. Each module includes activities, quizzes, and projects that cement the knowledge you acquire.
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Professional Certification: Complete the course to earn a certificate recognized across the clinical research industry. This credential will enhance your resume and validate your expertise to potential employers.
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Flexible Online Format: With an online schedule, you can learn from anywhere, fitting your studies around existing work or academic commitments.
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Live Project Experience: By working on real-world projects, you’ll build a portfolio of applied skills, making you a more attractive candidate for clinical data roles.
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Networking Opportunities: Connect with instructors and other students, creating a network of peers and professionals in the clinical research field.
- Career Support: Get guidance on how to apply your skills in the workforce, with insights on job roles, application tips, and career growth.
Limited Spots Available - Don’t miss out on this opportunity to upskill and kickstart or elevate your career in Clinical Data Management.
