Banke Odekanyin
Clinical Data Manager
Burford,GA
Summary
With over 8 years in clinical data management, led multiple studies and teams for sponsor companies and CROs. Expert in eCRF design, edit checks, User Acceptance Testing (UAT), data reconciliation, cleaning, and query resolution across all study stages. Proficient in pharmaceutical standards (CDISC, SDTM, CDASH, WHO Drug, ICH/GCP, GCDMP, FDA) and 21 CFR Part 11, with extensive AWS experience.
Overview
9
9
years of professional experience
Work History
Senior Clinical Data Manager
CTI Clinical Trials
1 2022 - Current
- Managed all phases of data management, led project initiatives
- Created, reviewed, approved study startup documents, eCRF/Database specifications, Edit Check specifications, Data Management Plan (DMP), UAT Plan
- Supervised data cleaning, processed queries, performed ongoing data review, ensuring data integrity
- Responsible for all database building activities, validation, execution of User Acceptance Testing (UAT)
- Oversaw eCRF design, Edit checks creation, User Acceptance Testing, ensured adherence to project timelines, quality standards
- Utilized Python for data manipulation, transformation, analysis, improving efficiency
- Represented Data Management, led study project initiatives, internal, client meetings
- Actively reviewed study data quality, provided data management metrics, reported out-of-scope activities to managers
- Assisted in DM oversight role, monitored timelines, managed resources, met study deadlines
- Identified inefficiencies in data management processes, implemented solutions, directed team members, trained, supervised Clinical Data Managers I and II.
- Improved communication between departments through regular status updates and issue resolution meetings, leading to smoother project progression
- Collaborated with global teams to develop unified data management practices, improving consistency across projects
- Implemented effective risk management strategies to minimize potential issues during clinical trial execution
Clinical Data Manager I, II, Lead Clinical Data Manager
IQVIA
01.2017 - 01.2022
- Primary contact for Sponsor on data management deliverables, contributed to UAT, ensured adherence to SOPs, study protocols
- Programmed edit checks, EDC system functions optimizing data quality, efficiency, 20% reduction in data query rates
- Created database specifications for new study EDC systems, enhanced data capture, management
- Developed Data Validation Specifications (DVS), ensured data quality, 15% error reduction, improved study outcomes
- Managed data cleaning activities, reviewed, managed queries, developed study metrics, 25% improved data accuracy, efficiency
- Presented project-specific slides, represented Data Management at Bid Defense Meetings (BDM), ensured effective communication, alignment with stakeholders
- Coordinated study database lock, freeze, archiving activities, ensured compliance with regulatory guidelines, SOPs
- Monitored study progress, adjusted plans proactively, identified priorities, timeline issues, achieved study targets
- Developed key clinical data management deliverables, CRF design, completion guidelines, database specifications, data management plans, contributed to successful study execution, data integrity.
Clinical Data Associate
FORUM Pharmaceutical
01.2015 - 01.2017
- Assisted in all Data Management tasks, ensured adherence to Data Management Review Plan guidelines
- Identified, generated data queries during data processing, optimized data quality, integrity
- Conducted quality control, case report form to database review processes, maintained data accuracy
- Organized data entry functions ensured efficient data management
- Contributed to study case report form (CRF) design, enhanced data collection methods
- Organized clinical digital images, managed blind assessment activities, supported clinical trials
- Conducted basic Data Management analysis of study data using MS Excel, Access, or similar tools
- Assisted in preparation of Clinical Summary Reports, provided insights into study outcomes
- Contributed to ongoing development of Data Management Plan, ensured protocol compliance
- Provided functional oversight of data processing activities, trained staff on data entry, cleaning, quality control tasks
- Developed study working folders for assigned protocols, ensured complete source documentation, protocol compliance.
Education
BSc in Biology -
Mercer University
Atlanta, GeorgiaSkills
- Proficient in EDC Systems: IBM, Inform, Medidata Rave
- Knowledgeable in IVRS/IWRS Systems: Almac, Bracket
- Expertise in CTMS: IMPACT
- Competent with e-TMF Systems: Trial Interactive, Veeva Vault
- Advanced skills in Python for data manipulation, transformation, analysis
- Data Management Leadership: Achieved 95% data accuracy at CTI Clinical Trials through rigorous data reconciliation and cleaning processes
- Technical Proficiency: Implemented Python scripts reducing manual data handling time by 40%, enhancing data quality
- Regulatory Compliance: Ensured adherence to 21 CFR Part 11 and other standards, contributing to successful FDA audits
Therapeutic Area Experience
Phase 1 to 3 therapeutic area experience in Oncology, Lymphoma, Breast Cancer, Lung Cancer, Prostate Cancer, Rare Diseases, CNS, Parkinson’s, Alzheimer’s, Neurofibromatosis, Pulmonology, Asthma, COPD, Pulmonary Fibrosis.
Timeline
Clinical Data Manager I, II, Lead Clinical Data Manager
IQVIA
01.2017 - 01.2022
Clinical Data Associate
FORUM Pharmaceutical
01.2015 - 01.2017
Senior Clinical Data Manager
CTI Clinical Trials
1 2022 - Current
BSc in Biology -
Mercer University
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