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Nola Lasisi

@nolalasisi

Senior Clinical Data Manager at Johnson and Johnson, leading global trial data quality and database lock readiness.

At Johnson and Johnson, I lead sponsor-side data management for concurrent global Phase II and III trials across Oncology, Immunology, and Neuroscience. I oversee CRO deliverables, SAE and vendor reconciliation, and database lock readiness, while supporting regulatory submission preparation.

Previously, I managed clinical data at Aslan Pharmaceuticals, Syneos Health, and Atlantic Research Group. My work has included EDC validation, data cleaning, query management, and inspection readiness across therapeutic areas including CNS and Rare Disease.

Experience

Work history, roles, and key accomplishments

Current

Senior Clinical Data Manager

Current

Johnson and Johnson

Jan 2023 - Present (3 years 9 months)

Lead sponsor-side clinical data management for 4-6 concurrent Phase II and III global trials across Oncology, Immunology, and Neuroscience. Oversee CRO deliverables, SAE reconciliation, UAT, and database lock readiness.

Medidata EDC Veeva CDMS Data Management Plans (DMPs)Edit Check Specifications CRF Completion Guidelines ICH GCP SAE Reconciliation UAT Edit Check Validation Clinical Metrics Reporting Database Lock Readiness Inspection Readiness CDISC SDTM Risk Based Data Review Cross functional Leadership

Clinical Data Manager

Aslan Pharmaceuticals

Oct 2021 - Dec 2022 (1 year 2 months)

Led database lock and ensured submission-ready datasets for regulatory filings. Directed development of Data Management Plans and oversaw database design, CRF development, and EDC validation.

Database Lock Data Management Plans (DMPs)CRF Development EDC Validation Query Management Data Cleaning Reconciliations ICH GCP FDA EMA CDISC SDTM Audit Readiness CRO Oversight CAPA

Clinical Data Manager

Syneos Health

Oct 2019 - Sep 2021 (1 year 11 months)

Managed end-to-end clinical data management for 3-5 concurrent Phase II and III CNS and Oncology trials in a global CRO environment. Conducted data cleaning, discrepancy management, and query resolution in Medidata Rave and Veeva Vault CDMS.

Medidata EDC Veeva CDMS Data Cleaning Query Management Data Management Plans (DMPs)Edit Check Specifications CRF Completion Guidelines UAT Edit Check Validation SAE Reconciliation Vendor Reconciliation Clinical Metrics Reporting Database Lock Readiness Mentorship

Clinical Data Manager

Atlantic Research Group (ARG)

Oct 2016 - Sep 2019 (2 years 11 months)

Managed clinical data management for 2-4 concurrent Phase I through III trials in Immunology, Rare Disease, and Oncology. Led data cleaning, query generation, and discrepancy tracking in Medidata Rave and Oracle Inform EDC systems.