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Elizabeth Ronke Aluko

@elizabethronkealuko

I lead clinical data teams from study setup through database lock.

I've led clinical data management across Phase I–IV studies for Fortrea, Gilead Sciences, GlaxoSmithKline, Pfizer, Abbott Laboratories, IQVIA, and Veristat.

At Fortrea, I managed study setup, conduct, and closure in EDC RAVE for obesity and inflammatory studies, coordinating vendor and sponsor task initiation, kick-off meetings, daily data management activities, query management, and external data oversight.

Across Gilead and GSK, I managed EDC study setup, eCRF screens, e-Diaries, e-Devices, vendor selection, service-level agreements, data reconciliation, and database lock activities. I have also supported real-world data studies and worked with safety, genetics, pharmacokinetics, spirometry, ECG, laboratory, clinical, and statistics teams.

With 22 years in clinical data management and quality, I bring practical experience in vendor risk assessment, GCP/ICH processes, pharmacovigilance, regulatory and drug safety, outsourced studies, and mentoring junior staff.

Experience

Work history, roles, and key accomplishments

Project Data Team Lead

Fortrea

Sep 2024 - Nov 2025 (1 year 2 months)

Managed study set up, conduct, and closure in EDC RAVE for obesity and inflammatory studies. Oversaw data management team, query management, and external data oversight.

Project Management Data Management Query Management Vendor Management

Project Data Team Lead

Veristat

Dec 2021 - Sep 2022 (9 months)

Managed studies in conduct phase, including vendor and sponsor task initiation meetings, kick-off meetings, and data management team meetings. Ensured query management through database lock.

Project Management Data Management Query Management Vendor Management

Project Data Team Lead

IQVIA

Jan 2021 - Jun 2021 (5 months)

Managed study set up and conduct in EDC RAVE for HIV, hepatitis, and inflammatory studies. Organized data management team meetings and ensured query management through database lock.

Project Management Data Management Query Management

Project Lead Data Manager

Gilead Sciences

Jun 2019 - Sep 2020 (1 year 3 months)

Managed study set up in EDC RAVE for HIV, hepatitis, and inflammatory studies. Assisted in vendor selection, reviewed work orders, and managed data queries and safety data reconciliation.

Data Management Vendor Management Query Management

Project Lead Data Manager

GlaxoSmithKline

Oct 2010 - Apr 2019 (8 years 6 months)

Managed study set up for EDC studies in respiratory therapeutic area. Designed eCRF screens, developed e-diaries and e-devices, and ensured data reconciliation for SAE, genetics, PK, spirometry, ECG, and lab data.

EDC Diaries Devices Data Management Query Management Vendor Management

Quality Manager

Actelion Pharmaceuticals

Aug 2009 - Aug 2010 (1 year)

Assisted study teams in selecting external service providers for electronic data collection devices. Conducted risk assessments and provided guidance on user acceptance testing and documentation.

Vendor Selection Risk Assessment User Acceptance Testing GCP Quality Management

Project Lead Data Manager

Pfizer

May 2004 - May 2005 (1 year)

Managed three phase 4 studies from start up to database lock. Trained and mentored junior staff, performed SAE and lab data reconciliation, and updated study status reports.

Data Management Training Mentor SAE Reconciliation Lab Data Reconciliation

Project Lead Data Manager

Abbott Laboratories

Feb 2003 - Apr 2004 (1 year 2 months)

Provided input into data validation documents and SOPs. Managed three outsourced studies to CROs, prepared validation plans, and chaired validation meetings.

Data Validation SOP Development CRO Management Validation Study Plans CRF Design

Project Data Manager

Pfizer

Sep 2001 - Dec 2002 (1 year 3 months)

Chaired meetings with clinical and statisticians to review CRFs and compiled validation documents. Edited patient data and coordinated database closure activities.

CRF Validation Data Editing Database Closure Safety Reconciliation

Clinical Data Manager

Wyeth-Ayerst Research

Sep 1999 - Sep 2001 (2 years)

Supported study set-up activities including CRF review and database validation. Planned and checked batch validation jobs, and reconciled SAE and lab data.

CRFs Review Data Validation SAE Reconciliation Lab Data Reconciliation