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6 months · Offline / Online

PG Diploma in Clinical Data Management (PGDCDM) in Pune

6-month PG Diploma in Clinical Data Management (PGDCDM) in Pune at iLearn CRI: full CDM lifecycle, CRF/eCRF design, EDC platforms (Medidata Rave, Oracle Clinical, Veeva Vault CDMS), CDISC standards, medical coding, database lock, and clinical SAS. ₹65,000 + GST (EMI available). Offline & online batches with direct placement support.

Duration
6 months
Mode
Offline / Online
Fees
₹65K

A deeper, hands-on route into clinical data management

If you are a B.Pharm, M.Pharm, B.Sc, M.Sc, BCA, or B.Tech graduate who wants a serious, data-focused career in clinical research — not just an introductory credential — the PG Diploma in Clinical Data Management (PGDCDM) is built for you. In six months, it takes you from the fundamentals all the way through database build, validation, medical coding, CDISC standards, database lock, and an introduction to clinical SAS.

This is the deeper, more hands-on version of our 3-month Certificate. Where the Certificate gives you a working foundation, the PG Diploma puts you inside real EDC study builds across Medidata Rave, Oracle Clinical/InForm, and Veeva Vault CDMS, walks you through the full CDM lifecycle, and gives you a portfolio you can show hiring managers. Clinical Data Management is also one of the most remote-friendly careers in the industry, which makes this one of the smartest specialisations for graduates who want strong, stable, work-from-anywhere prospects.

Pune is the right place to train. The Hinjewadi-Wakad-Bhosari corridor houses clinical data operations for CROs including Syngene, Veeda Clinical Research, Lambda Therapeutic Research, IQVIA, ICON, and Parexel, alongside sponsors Cipla, Sun Pharma, and Lupin — all of whom hire trained CDM talent continuously.

What you will learn

The diploma is built around how Pune CROs actually run data management, sequenced from study setup through database lock.

The full CDM lifecycle. You learn where data management sits across Phase I–IV trials, how the CDM team is structured, and how ALCOA+ and ICH-GCP E6(R3) data principles govern every step of the work.

CRF/eCRF design and database build. You map protocols to CRFs, write annotated CRFs and Completion Guidelines, design eCRF forms, specify edit checks, and validate the build through user acceptance testing before go-live.

EDC platforms and data validation. You get hands-on Medidata Rave study builds plus structured coverage of Oracle Clinical/InForm and Veeva Vault CDMS, then work through the full query lifecycle — discrepancy identification, query resolution with sites, and data review metrics.

Coding, reconciliation, CDISC, and clinical SAS. You code adverse events into MedDRA and medications into WHODrug, reconcile SAEs against the safety database, work through the full CDISC stack (CDASH, SDTM, ADaM, Define-XML), execute database lock, and finish with an introduction to clinical SAS for data extraction and derivations.

How the course is structured

PGDCDM runs over six months in both offline (classroom) and online batches, so you can attend in person at our Wakad campus or join live from anywhere in India. Weekday-evening and weekend batches are available for working professionals, and EMI installment plans spread the ₹65,000 fee across the programme.

Faculty are practising clinical data professionals — data managers, a CDISC SME, and a clinical SAS programmer — not full-time academics. They teach from the actual study builds, edit check failures, and lock-day escalations they handled in the last quarter, and the later modules are dedicated to hands-on portfolio work and placement readiness.

Placement infrastructure

We treat placement as a deliverable, not an afterthought. Every student completes structured placement preparation: CDM-focused resume calibration, a hands-on portfolio (a full Rave study build, an SDTM mapping exercise, and a query lifecycle case study), and mock interviews with practising data managers from partner CROs — technical, scenario-based, and behavioural. We then make direct introductions to our 50+ CRO and pharma partners across Pune. Starting CTCs for PGDCDM graduates typically range from ₹3.6 to ₹5.0 LPA depending on the role and your degree, with clear progression to senior and lead roles as you specialise in CDISC, EDC, or clinical SAS.

Who this course is right for

You will get the most out of PGDCDM if you are:

  • A graduate with an analytical bent (B.Pharm, M.Pharm, B.Sc, M.Sc, BCA, B.Tech) who wants a data-focused clinical research career
  • Someone who wants more depth than a certificate — real database builds, multi-platform EDC, and full CDISC coverage
  • Attracted to a remote-friendly career with strong, stable demand across Indian and global CROs
  • A working professional from a pharma or data background who wants to move into structured clinical data management

Apply for the next batch

Batches start regularly, with limited seats per batch to protect faculty attention, hands-on platform access, and placement quality. Early applicants get priority for placement preparation and corporate partner introductions.

Reach out via WhatsApp for an immediate conversation about your background and the right intake batch for you.

If you want to compare depth or a specific specialisation, the natural options are:

Further reading

Online & classroom

Available online and in the classroom

The PG Diploma in CDM course runs as two separate batches — a live online batch and an offline classroom batch at our Wakad campus — so you can train from anywhere in India or attend in person in Pune. Both run weekday evenings and full Saturdays, and both are fully instructor-led by practicing professionals.

Live online batch

Fully instructor-led live sessions with independent remote hands-on access to the same platforms (Argus, Medidata Rave, eCTD tools) and the same placement support — so you build a real portfolio from home. Designed for students across India and working professionals who can't relocate to Pune.

Classroom batch (Pune)

In-person at our Wakad campus in the Hinjewadi-Wakad corridor, with hands-on lab access and face-to-face faculty time — ideal for Pune-based students who want maximum platform practice.

Not sure which batch suits you? Talk to admissions about the current schedule, or see all online clinical research courses.

Curriculum

What you’ll learn, module by module.

  1. 01 Foundations of Clinical Research & Drug Development
    • The drug development lifecycle, discovery to post-marketing
    • Key stakeholders: sponsors, CROs, sites, investigators, IRB/IEC
    • Phases of clinical trials (Phase I–IV) and their objectives
    • How the Indian and global clinical research industry is structured
  2. 02 ICH-GCP & Ethics
    • ICH-GCP E6(R3) principles and the core requirements
    • Informed consent process and documentation
    • The Declaration of Helsinki and ethical foundations
    • Roles of sponsor, investigator and monitor
  3. 03 Regulatory Framework
    • CDSCO and the New Drugs and Clinical Trials Rules 2019 (India)
    • EMA and the EU Clinical Trials Regulation — overview
    • USFDA 21 CFR Parts 11, 50, 56 and 312 — overview
    • Regulatory submissions and approval pathways at a glance
  4. 04 Clinical Trial Documents & Data
    • Protocol, Investigator's Brochure and the essential document set
    • Introduction to EDC and the Trial Master File (TMF)
    • Case Report Forms (CRFs) and source documentation
    • ALCOA+ data integrity principles
  5. 05 Monitoring & Safety Basics
    • Types of monitoring visits and the CRA's role
    • Adverse events, serious adverse events and safety reporting
    • Source data verification (SDV) fundamentals
    • Protocol deviations and quality management
  6. 06 Introduction to Clinical Data Management
    • The Clinical Data Management process and its objectives
    • CDM team structure: data manager, coordinator, programmer
    • Introduction to CDM tools and software
    • Role of CDM within the clinical trial lifecycle
    • Indian and global CDM landscape and career pathways
  7. 07 Guidelines & Data Standards for CDM
    • Documentation scenario for data collection and management
    • International studies and data privacy requirements
    • Guidance for industry: ISO, ICH, HL7, CDISC and CDASH
    • Electronic source data in clinical investigations
  8. 08 Study Setup & CRF Design
    • Protocol-to-CRF mapping and design principles
    • Edit check specification and validation logic
    • User acceptance testing (UAT) and go-live procedures
    • Annotated CRF (aCRF) and CRF Completion Guidelines
    • EDC study build: Medidata Rave hands-on
  9. 09 Data Entry & Discrepancy Management
    • Data entry workflows in EDC systems
    • Manual review vs automated edit check resolution
    • Data review metrics and site performance tracking
    • Discrepancy identification and the query lifecycle
    • Site communication for query resolution
  10. 10 Standard Coding & Safety Reporting
    • MedDRA coding: hierarchy, conventions and version migration
    • CDISC standards: CDASH, SDTM and ADaM overview
    • WHO-DD drug coding and dictionary management
    • Coding consistency and quality control
  11. 11 Data Review & Data Transfer
    • External data reconciliation: lab, ECG, IRT, ePRO
    • Listings review and data cleaning sign-off
    • Data transfer specifications and integration standards
    • CDISC Define-XML and Reviewer's Guide preparation
  12. 12 SAE Reconciliation
    • SAE reporting workflow: site to sponsor to safety database
    • Discrepancy identification and resolution between databases
    • CDM–safety database reconciliation process
    • Regulatory reporting timelines and CDM's role
  13. 13 Database Closure & Archiving
    • Pre-lock checklist and quality review procedures
    • Post-lock unlock procedures and documentation
    • Long-term data retention and regulatory requirements
    • Database lock protocols and authorisation workflow
    • Trial Master File (TMF) archiving requirements
  14. 14 Quality Control (QC) & Quality Assurance (QA)
    • QC vs QA: definitions and scope in CDM
    • Audit trail review and data integrity checks
    • Inspection readiness for CDM systems and processes
    • Risk-based data monitoring principles
    • GCP compliance in data management operations
  15. 15 Tools: Medidata Rave, Oracle Clinical, CDISC
    • Medidata Rave: study build, forms, edit checks and reporting
    • CDISC SDTM mapping exercises
    • Veeva Vault EDC overview and industry adoption
    • Oracle Clinical / InForm: overview and when it is used
    • SAS programming basics for CDM: data steps and PROC SQL
  16. 16 AI in Clinical Research
    • Introduction to AI, machine learning and deep learning basics
    • Modern and adaptive clinical trial design
    • Remote patient monitoring and patient e-diaries
    • Evolution of AI across healthcare and the drug development lifecycle
    • Virtual and decentralised trials: e-consent, ePRO, IWRS, telemedicine
  17. 17 AI in Managing Clinical Data
    • Types of healthcare data, databases and AI-enabled platforms
    • NLP for automated coding and unstructured clinical narratives
    • Governance, validation and 21 CFR Part 11 expectations for AI tools
    • ML-assisted CRF design and risk-based data review
    • Anomaly detection and central statistical monitoring
  18. 18 Career Readiness & Placement Prep
    • Clinical research and CDM resume building for freshers
    • Industry roles, entry paths and choosing between the two tracks
    • Mock interviews with practising clinical research professionals
    • Certification pathways and next steps after the diploma
Career outcomes

Roles graduates step into.

  • Clinical Data Coordinator
    Avg. CTC ₹ 3.6–4.5 LPA
  • Clinical Data Associate
    Avg. CTC ₹ 4.0–5.0 LPA
  • Clinical Data Manager
    Avg. CTC ₹ 5.0–7.0 LPA
  • CDISC / EDC Specialist
    Avg. CTC ₹ 6.0–9.0 LPA
  • Senior CDM (3–5 years)
    Avg. CTC ₹ 8.0–12.0 LPA
  • Lead / Data Team Lead
    Avg. CTC ₹ 12.0–18.0 LPA
Placements

Where clinical research careers start in Pune.

Our placement record reflects what most clinical research institutes in Pune don’t measure: not just where you start, but how fast you grow inside pharma and CROs.

Alumni Working Across Pharma
50+

Alumni Working Across Pharma & CRO Industry

Average Industry Starting CTC
₹4.2L

Average Industry Starting CTC

Placement Assistance Support
100%

Placement Assistance Support

Pharma & CRO Hiring
50+

Pharma & CRO Hiring Partners

FAQ

Questions about the PG Diploma in CDM

Can’t find your answer? Reach out on WhatsApp—we usually reply within an hour during business days.

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What is the fee for the PG Diploma in Clinical Data Management in Pune?

The 6-month PG Diploma in Clinical Data Management (PGDCDM) at iLearn CRI in Pune is ₹65,000 + 18% GST. The fee covers all course materials, hands-on Medidata Rave study build access, CDISC reference materials (CDASH, SDTM, ADaM), a clinical SAS practice environment, and structured placement preparation. EMI options are available, and most students opt for a multi-installment plan spread across the programme.

Is the PG Diploma in Clinical Data Management available online?

Yes. PGDCDM runs in both offline (classroom) and online batches, so you can attend in person at our Wakad, Pune campus or join live from anywhere in India. Both modes follow the same curriculum, the same faculty, and the same hands-on EDC and CDISC work. Because CDM is one of the most remote-friendly clinical research careers, many students choose the online or hybrid batch and go on to work in fully remote data management roles.

What is the difference between the Certificate and the PG Diploma in Clinical Data Management?

The Certificate in Clinical Data Management is a focused 3-month foundation covering EDC basics, CDISC awareness, and core data management workflows — ideal for a quick entry credential. This PG Diploma (PGDCDM) is a deeper, more hands-on 6-month programme that adds full database build and validation, multi-platform EDC work (Medidata Rave, Oracle Clinical/InForm, Veeva Vault CDMS), medical coding, SAE reconciliation, complete CDISC coverage, and an introduction to clinical SAS. Many students step up from the Certificate to the PG Diploma as they commit to a CDM career.

Which EDC platforms and standards does the PG Diploma cover?

You get hands-on training in Medidata Rave — the Indian CRO market leader — and structured coverage of Oracle Clinical/InForm and Veeva Vault CDMS, so you can map your skills across the platforms Pune employers actually use. On standards, the diploma covers the full CDISC stack: CDASH for data collection, SDTM for tabulation, ADaM for analysis, and Define-XML preparation, alongside MedDRA and WHODrug medical coding.

Do I need programming or SAS experience before joining?

No. The diploma includes an introduction to clinical SAS built for beginners — Base SAS, PROC SQL for CRF extraction, and basic derivations. You will not become a senior SAS programmer in six months, but you will be conversant enough to extract data, write simple derivations, and read existing SAS code, which is the level expected of a Clinical Data Associate or Coordinator moving toward CDISC and EDC specialist roles.

Does the PG Diploma include placement support?

Yes. Every student receives full placement assistance: resume calibration for CDM roles, a hands-on portfolio (a Rave study build, an SDTM mapping exercise, and a query lifecycle case study), mock interviews with practising data managers, and direct introductions to our 50+ CRO and pharma partners across Pune. Final placement depends on individual performance, but the support infrastructure is comprehensive.

Who hires Clinical Data Management professionals in Pune?

Pune's CDM employer base includes CROs such as Syngene International, Veeda Clinical Research, Lambda Therapeutic Research, IQVIA, ICON, and Parexel, along with the in-house data teams of sponsors like Cipla, Sun Pharma, and Lupin. Because CDM is one of the most remote-friendly clinical research careers, opportunities are not limited to Pune-based employers — global CROs regularly hire CDM staff for their India delivery centres.