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Temiloluwa User

@temiloluwauser2

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Clinical Data Manager with 6+ years leading Phase III oncology data management and regulatory-ready documentation.

Nigeria

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What I'm looking for

I’m looking to lead end-to-end clinical trial data management—EDC/eCRF design, CDISC-standardization, query lifecycle, and database lock—within GCP-focused teams, collaborating with clinical, biostatistics, and regulatory to deliver inspection-ready quality.

I’m a Clinical Data Manager with 6+ years of progressive experience leading clinical trial data management across multinational Phase III oncology studies. I’m experienced in Rave EDC, eCRF design and testing, CDISC standards (CDASH, SDTM), query lifecycle management, and database lock procedures—backed by GCP certification (CITI).

I’ve maintained 98% data quality scores, ensured 100% protocol compliance, and produced regulatory inspection-ready documentation across 12+ clinical sites in multiple countries. From cross-functional collaboration to training 40+ clinical staff and supporting research outputs (8+ publications), I focus on data validation, reconciliation, and TMF-quality documentation that keeps studies moving with confidence.

Experience

Work history, roles, and key accomplishments

Current

Data Manager

Current

IMbrave152/SKYSCRAPER-14 Study

Jan 2023 - Present (3 years 6 months)

Led data management operations for a multinational Phase III oncology trial, ensuring protocol and regulatory compliance. Designed eCRF completion guidance, managed 200+ clinical queries, performed data validation and reconciliation, and coordinated eCRF freeze/database lock with 12+ sites across 3 countries while maintaining strong data quality and TMF documentation.

Data Reconciliation Database Lock Trial Master File (TMF)Regulatory Documentation GCP

Current

Data Manager and Analyst

Current

ARETTA Clinical Trial

Jan 2020 - Present (6 years 6 months)

Collaborated with clinical teams to standardize EHR documentation and improve data quality workflows through committee participation and data validation process improvements. Delivered training to 40+ staff, developed data capture guidelines/SOPs, and supported research publication and manuscript preparation.

Data Validation Training SOP Development Clinical Data Management Research Data Support

Patient Relations Specialist, Data Mgr

Breast Cancer Clinic, LUTH

Jan 2018 - Dec 2019 (1 year 11 months)

Designed and implemented questionnaires for prospective data collection and ensured patient data was entered and validated within approved templates and databases. Performed quantitative and qualitative data analysis using SPSS/STATA/EPI INFO, supported publications and presentations, and mentored 5+ junior team members in statistical analysis and interpretation.