CCDM® Certified · Open to Opportunities

Turning Complex
Data Into
Clinical Certainty

4+ years leading end-to-end data management for Phase I–IV clinical trials. CDISC, ICH-GCP, audit-ready delivery.

Explore Experience → Download CV
Key Achievement

100% Audit-
Readiness
Score

Ensured timely database lock for 3 Phase II studies with zero major audit findings and full regulatory compliance.

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Technical Expertise

Medidata.
Medrio. REDCap.
And Beyond.

Experienced across 6+ EDC platforms with deep knowledge of CDISC/SDTM, MedDRA coding, and SAE reconciliation.

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Experience with
SGS Nutrasource CORE – Ocular Research LMC MannaHealthcare BiopharmaService Clinosoft Research
Medidata Rave Medrio EDC REDCap CDISC / SDTM ICH-GCP CCDM® Certified SAE Reconciliation Database Lock MedDRA Coding Veeva Vault SAS 9.4 Phase I–IV Trials Medidata Rave Medrio EDC REDCap CDISC / SDTM ICH-GCP CCDM® Certified SAE Reconciliation Database Lock MedDRA Coding Veeva Vault SAS 9.4 Phase I–IV Trials
Neel Gajjar
4+ Years in CDM
Who I Am

Clinical Data Manager
with Purpose

I'm Neel Gajjar, a Certified Clinical Data Manager (CCDM®) with over 4 years of experience driving data quality and regulatory compliance across Phase I–IV clinical trials. I hold a Bachelor of Pharmacy and a Post-Graduate Diploma in Clinical Research, Drug Safety & Pharmacovigilance.

What motivates me is knowing that clean, accurate clinical data is the foundation of safe medicine. Every edit check, every query resolved, and every database lock I manage brings a treatment one step closer to the patients who need it.

Currently based in Waterloo, ON, I'm actively seeking hybrid or remote Clinical Data Manager roles across Canada and internationally.

3
Phase II studies locked with 100% audit score
25%
Reduction in query resolution time
6+
EDC platforms mastered
5
Therapeutic areas covered
Career

Professional Experience

Clinical Data Manager II
SGS Nutrasource · 2023–Present
Data Management Coordinator
CORE · 2022–2023
Clinical Trial Assistant
LMC MannaHealthcare · 2021–2022
Clinical Data Associate
BiopharmaService · 2021
Clinical Data Manager II
SGS Nutrasource · Guelph, ON
Nov 2023 – Present EDC: Medrio Phase I–IV
  • Lead end-to-end data management for Phase I–IV clinical trials ensuring compliance with ICH-GCP and CDISC (SDTM, CDASH) standards
  • Design, review, and validate EDC databases and eCRFs; develop DMPs, database lock plans, and data transfer agreements
  • Perform comprehensive data cleaning, query management, SAE reconciliation, and medical coding resolution
  • Provide strategic vendor oversight, tracking timelines, quality metrics, and adherence to milestones
  • Conduct UAT, manage database user access, and provide EDC training to site coordinators and CRAs
  • Lead knowledge-sharing sessions and drive continuous process improvement within the data management team
🏆 100% Audit-Readiness — 3 Phase II Studies ⚡ 25% Reduction in Query Resolution Time
Data Management Coordinator
Centre for Ocular Research & Education (CORE) · Waterloo, ON
Mar 2022 – Oct 2023 EDC: REDCap, Medidata Rave
  • Managed end-to-end CDM activities for ophthalmic clinical trials ensuring high-quality, audit-ready data delivery
  • Reviewed and updated DMPs, Edit Check Specifications, eCRF Completion Guidelines, and Lab Data Transfer Specifications
  • Performed UAT, SAE reconciliation, lab reconciliation, and medical coding using MedDRA and WHO-DD
  • Managed eTMF (Veeva Vault) system including uploading and maintaining all study documents
  • Generated and shared weekly status reports and performance metrics with study teams
  • Executed pre-lock and lock checklists and conducted post-lock activities including CRF PDF generation and data archival
Clinical Trial Assistant
LMC MannaHealthcare · Toronto, ON
Oct 2021 – Mar 2022 EDC: Inform, RealTime CTMS
  • Performed accurate and timely data entry of electronic and paper CRFs into EDC systems per GCP guidelines
  • Created and maintained the Investigator Site File in RealTime CTMS in accordance with GCP and institutional SOPs
  • Assisted Clinical Research Coordinators in responding to data management queries and addressing monitoring findings
  • Managed receipt, storage, and organization of Investigational Products ensuring adherence to study protocols
Clinical Data Associate (Co-op)
BiopharmaService Inc. · Toronto, ON
Sep 2021 – Oct 2021 EDC: Medrio
  • Performed data management activities in compliance with GCP guidelines and Standard Operating Procedures
  • Conducted quality control (QC) reviews of entered clinical trial data ensuring accuracy and completeness
  • Created, reviewed, and processed data queries ensuring timely database updates and resolution of discrepancies
Featured Work

Project Highlights

01
Phase II Database Lock — 3 Concurrent Studies
Led end-to-end data management for 3 simultaneous Phase II clinical studies, achieving 100% audit-readiness and locking all databases on schedule with zero major findings.
MedrioICH-GCPSAE ReconciliationDatabase Lock
02
Query Resolution Process Redesign
Redesigned edit check processes and delivered targeted training programs to site coordinators, resulting in a measurable 25% reduction in query resolution time across all active studies.
Edit ChecksSite TrainingProcess Improvement
03
Ophthalmic Trial Full CDM Lifecycle
Coordinated complete CDM lifecycle for ophthalmic clinical trials using Medidata Rave and REDCap, including lab reconciliation, MedDRA coding, and full eTMF management in Veeva Vault.
Medidata RaveREDCapMedDRAVeeva Vault
Technical Expertise

Skills & Tools

EDC Systems
Medidata RaveMedrioREDCapVeeva EDCInformTrialMaster
Standards & Compliance
CDISCSDTMCDASHICH-GCPMedDRAWHO-DD
Programming & Analytics
SAS 9.4RPythonVBAPower BI
Therapeutic Areas
OphthalmologyEndocrinologyDermatologyNutraceuticalsMedical Devices
EDC Database Design & ValidationExpert
CDISC / SDTM / CDASH StandardsExpert
Query Management & Data CleaningExpert
SAE Reconciliation & Medical CodingAdvanced
SAS / R / PythonAdvanced
Vendor Oversight & Risk ManagementAdvanced
Cross-functional CollaborationExpert
Credentials

Education & Certifications

Academic Background

April 2022
PG Diploma – Clinical Research, Drug Safety & Pharmacovigilance
Academy of Applied Pharmaceutical Sciences (AAPS) · Toronto, ON
January 2018
Diploma – Chemical Laboratory Technician
Seneca College · North York, ON
May 2016
Bachelor of Pharmacy (B.Pharm)
Gujarat Technological University · Chandkheda, India

Professional Certifications

★ Flagship
CCDM®
Society for Clinical Data Management
2025
Good Clinical Practice
NIDA Clinical Trials Network
2022
Biomedical Research
CITI Program
2023
Health Canada Division 5
Health Canada
2023
TCPS2 Course
Panel on Research Ethics
2023
Clinical Project Mgmt
AAPS Inc.
2022
What People Say

Recommendations

"
Neel consistently demonstrated exceptional attention to detail and thorough understanding of regulatory requirements. His ability to manage multiple studies simultaneously while maintaining data quality was impressive.
Clinical Project Manager
SGS Nutrasource
"
Working with Neel on our ophthalmic trials was a pleasure. He brought real structure to our data management processes and was always proactive in identifying issues before they became problems.
Senior CRA
Centre for Ocular Research & Education
"
Neel's CCDM certification reflects his deep commitment to the field. He brings both technical expertise and a collaborative spirit — a genuinely valuable asset to any clinical data team.
Biostatistician
Clinical Research Organization

* Testimonials are representative. Full LinkedIn recommendations available on request.

Get In Touch

Let's Connect

Actively seeking Clinical Data Manager roles — hybrid or remote anywhere in Canada. If you're hiring or want to connect, I'd love to hear from you.

Email
nggajjar17@outlook.com
Phone
+1 (437) 777-2335
LinkedIn
linkedin.com/in/neelgajjar1710
Resume
Download CV (DOCX)

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