TUNDE OLALEYE
Houston,USA
Summary
Clinical data management professional with extensive experience in overseeing clinical trials and ensuring data integrity. Known for collaborative team efforts and achieving significant outcomes. Reliable and adaptable, excelling in database management and regulatory compliance, fostering high standards and results-oriented environments.
Over the years, I've successfully managed multiple studies from startup through database lock, ensuring clean, compliant, and analysis-ready data. Known for combining strong technical acumen in EDC systems with a keen understanding of clinical trial timelines, regulatory requirements, and cross-functional coordination.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Professional Development
Clinical Research
02.2024 - Current
- Dedicated years to upskilling in clinical research and drug safety via accredited platforms.
- Completed specialized pharmacovigilance training, emphasizing aggregate reporting, Individual Case Safety Reports, and Signal Management.
- Acquired practical knowledge in MedDRA coding, GCP compliance, and clinical trial operations.
- Studied pharmaceutical lifecycle through courses in Drug Discovery, Development, and Commercialization.
Clinical Data Manager
Anatomic
07.2022 - 01.2024
- I acted as Subject Matter Expert (SME) overseeing end-to-end management of clinical research projects across multiple therapeutic areas, ensuring adherence to timelines, scope, quality, and budgetary constraints.
- Supervised execution of clinical research activities, served as primary liaison with clients, and managed contractual deliverables and amendments to ensure alignment with project goals.
- Provided regular updates on project status, escalated issues as necessary, and implemented troubleshooting measures to maintain client satisfaction and ensure project milestones were met.
- Prepared and delivered comprehensive study updates, dashboards, and status reports to study teams, senior management, sponsors, vendors, and other stakeholders.
- Collaborated cross-functionally with departments such as Clinical Operations, Project Management, Programming, Biostatistics, to design and validate study specifications and data edits.
- Monitored and validated functionality of Electronic Data Capture (EDC) systems, ensuring integrated, efficient data management processes, and led sponsor interactions from data management perspective.
- Authored, reviewed, and revised key Data Management study documents, including Data Quality Management Plan, Data Validation Plan, Data Review Plan, Case Report Forms (CRFs), eCRF Completion Guidelines (CCGs), and Data Transfer Agreements (DTAs), ensuring alignment with quality standards and regulatory requirements.
- Developed, implemented, and continuously refined data management strategies, including plans, reports, validation protocols, and data entry procedures, to ensure efficient data processing, quality control, and timely reporting.
- Led data cleaning activities, including Serious Adverse Event (SAE) reconciliation and external data reconciliation, providing study metrics and status reports to internal and client teams.
- Coordinated creation of eCRF specifications based on study protocol and contributed to design and review of study databases.
- Managed and facilitated issue resolution with investigator site personnel, clinical trial vendors (e.g., central laboratories), and ensured compliance with project specifications and quality standards.
- Provided expert data management input during review of study protocols, statistical analysis plans, and other key project documentation. Assisted in tracking study metrics, including patient enrollment, data entry progress, and query resolution.
- Delivered comprehensive training and ongoing support to internal teams on best practices, processes, and systems related to clinical data management.
- Conducted data review and monitoring using Medidata Rave and Zelta (formerly IBM Clinical) for tracking study metrics, validating data, and managing data cleaning activities.
Intern
Lagos University Teaching Hospital
09.2019 - 05.2022
- Rotated through major clinical departments including Internal Medicine, Surgery, Pediatrics, Obstetrics & Gynecology, Emergency Medicine, and Community Medicine.
- Managed inpatient and outpatient care under supervision of consultants, including history taking, physical examinations, and clinical documentation.
- Developed differential diagnoses and management plans based on clinical evaluation, diagnostic findings, and evidence-based guidelines.
- Performed and assisted in variety of clinical procedures such as venipuncture, IV cannulation, wound suturing, urinary catheterization, and nasogastric tube insertion.
- Assisted in major and minor surgical procedures across General Surgery, Obstetrics & Gynecology, and Emergency departments.
- Participated in daily ward rounds, contributing to multidisciplinary team discussions and discharge planning.
- Interpreted laboratory and imaging results (X-rays, ECGs, ultrasound, basic CT scans) and correlated findings with clinical symptoms.
- Managed emergency cases in casualty/emergency department, including trauma care, resuscitation, and acute medical/surgical conditions.
- Delivered preventive care and health education during community outreach programs and public health rotations.
- Maintained accurate patient records and documentation in compliance with hospital standards and medical ethics.
- Developed professional communication skills through interactions with patients, families, nurses, and healthcare team.
- Demonstrated strong teamwork, adaptability, and time management in high-pressure clinical environments.
Education
M.D. - Medicine
Kharkiv National University V.N. Karazin
Ukraine07-2012
Bachelor of Science - Microbiology
Crawford University
Nigeria07-2019
Skills
- Reports Generation
- Data Analysis
- Data Entry
- Vendor Management
- Proficient in Microsoft Office
- WHODrug
- MedDRA
- Quality assurance
- Regulatory compliance
- Clinical data management
- Team management
- Pharmacovigilance aggregate reporting
- Pharmacovigilance ICSR
- Database maintenance and query resolution
- Excellent communication and interpersonal skills
- Clinical systems proficiency: EDC (Medidata Rave, Zelta, Inform, Medrio), CTMS (BioClinica, Veeva), eTMF (Veeva Vault)
- Attention to detail
- Problem solving
- Time management
- Data query management
- CDISC standards
- Data validation techniques
- Data reconciliation
- Signal detection & management
Certification
- Drug Discovery, Development, and Commercialization
- Clinical Trials: Good Clinical Practice
- MedDRA Training
- Pharmacovigilance Practical ICSR
- Pharmacovigilance Aggregate Reporting
- Signal Detection and Management in Pharmacovigilance
- Data Management for Clinical Research
Languages
English: Native/Bilingual
Therapeutic Areas
- Oncology: Solid tumor
- Infectious Disease: COVID-19
- Cardiovascular: Hypertension
Timeline
Professional Development
Clinical Research
02.2024 - Current
Clinical Data Manager
Anatomic
07.2022 - 01.2024
Intern
Lagos University Teaching Hospital
09.2019 - 05.2022
M.D. - Medicine
Kharkiv National University V.N. Karazin
Bachelor of Science - Microbiology
Crawford University
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