BABATUNDE OLALEYE, MD, B.Sc.
Houston,TX
Summary
Dynamic Senior Clinical Data Manager with proficiency in clinical data management and regulatory compliance at Anatomic. Proven ability to create in-depth reports and cultivate vendor relationships. Robust analytical skills enhanced by effective communication, consistently meeting project milestones while prioritizing client satisfaction.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Senior Clinical Data Manager/Drug Safety Associate
Professional Development
02.2024 - Current
- Dedicated over a year 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.
Senior Clinical Data Manager
Anatomic
07.2022 - 01.2024
- I acted as the Subject Matter Expert (SME) overseeing the end-to-end management of clinical research projects across multiple therapeutic areas, ensuring adherence to timelines, scope, quality, and budgetary constraints.
- Supervised the execution of clinical research activities, served as the 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 the functionality of Electronic Data Capture (EDC) systems, ensuring integrated, efficient data management processes, and led sponsor interactions from a data management perspective.
- Authored, reviewed, and revised key Data Management study documents, including the 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 the creation of eCRF specifications based on the study protocol and contributed to the 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 the 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 the 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 a 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 the 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 the healthcare team.
- Demonstrated strong teamwork, adaptability, and time management in high-pressure clinical environments.
Education
Doctor of Medicine -
Kharkiv National Medical University
Ukraine07.2019
Bachelor of Science -
Crawford University
07.2012
Skills
- Reports Generation
- Data Analysis
- Data Entry
- Vendor Management
- Proficient in Microsoft Office
- WHODrug
- MedDRA
- Quality Assurance
- Regulatory Compliance
- Clinical Data Management
- Team Management
- Database Maintenance & Query Resolution
- Excellent Communication and Interpersonal Skills
- Clinical Systems Proficiency: EDC (Medidata Rave, Zelta, Inform, Medrio), CTMS (BioClinica, Veeva), eTMF (Veeva Vault)
Certification
- Drug Discovery, Development, and Commercialization, Coursera, 04/16/25
- Clinical Trials: Good Clinical Practice, Coursera, 02/18/25
- MedDRA Training, Udemy, 01/23/25
- Pharmacovigilance Practical ICSR, Udemy, 11/15/24
- Pharmacovigilance Aggregate Reporting, Udemy, 10/14/24
- Data Management for Clinical Research, Coursera, 05/08/23
Therapeutic Areas
- Oncology: Solid tumor
- Infectious Disease: COVID-19
- Cardiovascular: Hypertension
Languages
English
Native/ Bilingual
References
References available upon request.
Timeline
Senior Clinical Data Manager/Drug Safety Associate
Professional Development
02.2024 - Current
Senior Clinical Data Manager
Anatomic
07.2022 - 01.2024
Intern
Lagos University Teaching Hospital
09.2019 - 05.2022
Doctor of Medicine -
Kharkiv National Medical University
Bachelor of Science -
Crawford University
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