Experience

Built around the
clinical data lifecycle.

Five years of progressive clinical data experience across Phase I–III studies, with hands-on responsibility spanning database design, validation, cleaning, reconciliation, documentation and lock readiness.

End-to-end clinical data management.

Lead data-management activities across Phase I–III randomized, blinded, placebo-controlled, crossover and ePRO-enabled studies, including database design, validation, live data oversight and lock preparation.

Protocol → eCRFProtocol review, eCRF specifications, edit checks, visit schedules, calculations and CDASH considerations.
EDC Build + UATBuild/configuration, dynamic logic, custom queries, access matrices, validation and production support.
Data QualityData cleaning, query management, missing-data review and cross-form consistency.
ReconciliationSAE, medical coding, central lab, ePRO and other external-data review.
Study DocumentationDMP, eCRF completion guidance, transfer agreements, release and lock documentation.
OversightVendor coordination, access/training support, metrics, TMF readiness, timelines and cross-functional delivery.
11Studies led
~11Medrio builds
~10UAT databases
3Concurrent studies, up to

Database support through archival.

Supported clinical databases and data-management deliverables across build, UAT, production review, reconciliation and closeout.

Database DeliveryApproximately 15 databases supported, with UAT across approximately 10 and production support across approximately 15.
SpecificationsProtocol/CRF review, DMP, build specifications, edit-check specifications, guidelines, reports and lab specifications.
Cleaning + CodingQuery management, SAE and lab reconciliation, MedDRA and WHO-DD workflows.
CloseoutPre-lock, database lock, archival and Veeva eTMF documentation support.

Foundation before specialization.

Earlier clinical trial assistant, data associate, trainee and pharmaceutical quality experience built the operational and documentation foundation that now informs my clinical-data work.

Technology matrix

Tools in context.

CLINICAL DATA

eCRF Design
UAT
Query Management
SAE Reconciliation
Lab Reconciliation
Database Lock

SYSTEMS

Medrio
Medidata Rave
REDCap
Veeva/Flex eTMF
RealTime CTMS
ePRO/eCOA

STANDARDS

CDISC / CDASH
SDTM familiarity
GCP
MedDRA
WHO-DD
Health Canada Division 5

AUTOMATION

Python
VBA
SAS 9.4
R
Power BI
Excel

Education

Clinical + scientific foundation.

AAPS

PG Diploma

Clinical Research, Drug Safety & Pharmacovigilance · 2021–2022

Seneca

Chemical Laboratory Technician

2016–2018

GTU

Bachelor of Pharmacy

2012–2016

See the work

Experience is stronger
when it can be demonstrated.

Projects →Data Lab