Shola Ogbodo
Summary
Experienced Clinical Data Manager with Project Management skills and ample Study Lead Experience from study Startup to Database Lock for Phases 1 - III Clinical Trials.
Therapeutic Areas; Oncology, Cardiovascular, Respiratory, Neurology, Infectious Diseases, Vaccines, Medical Device
Overview
6
6
years of professional experience
Work History
Clinical Data Manager
The Emmes Company
05.2021 - 01.2024
- Data Manager responsible for end-to-end DM activities for assigned studies
- Serve as primary study contact externally and internally for assigned studies
- Generate and review reports and listings as required to maintain data integrity
- Review, analyze and validate clinical trial data to ensure consistency, integrity, and accuracy based on study guidelines
- Perform quality control activities to ensure Data integrity
- Report routine status and trends to Management team on an ongoing basis
- Perform SAE, Safety and Lab data reconciliation
- Development and testing of edit checks
- Development of DM documents including CCGs, DMP, Entry Guidelines and DRP
- Review and resolve Automated and manual Data Queries
- Process user access requests to study platforms
- Perform UAT Testing.
Clinical Data Manager
Integrium Clinical Research
02.2019 - 04.2021
- Study Lead responsible for developing the Data Management Plans, Data Entry Guidelines, CCGs, Data Management Reports, and other documents required for preparing and completing databases
- Managed and supervised a Team of Clinical Data Coordinators
- Involved in reviewing job applications, conducting interviews and making hiring decisions with Management
- Responsible for all clinical data management activities and serves as primary point of contact for internal and external study team members
- Ensures that data cleaning is performed in a consistent way between team members
- Performed study/EDC trainings for Clinical Data Coordinators and site personnel
- Reviews CRFs, data listings, and database to ensure all captured data follow the rules outlined by the protocol and data management plan
- Reviews electronic discrepancies issues and resolve queries
- Updates the database based on query responses, as well as Self Evident Corrections
- Perform manual checks on CRF pages
- Perform SAE and External/3rd Party Data reconciliation
- Perform and track local lab data and entry modules
- Supports database development activities and coordinates database amendments in collaboration with the database development team
- Perform ongoing listing review and Quality Control activities
- Assists with the development and testing of data entry screens and edit checks
- Perform extensive UAT testing.
Clinical Data Coordinator
Syneos Health (Contractor)
02.2018 - 01.2019
- Assist in the preparation of data management plans, data entry guidelines, data management reports and other documents required for preparing and completing databases
- Perform user acceptance/database testing to ensure the quality and integrity of the study database design and associated edit check programming prior to the study database going live
- Ensure data quality and consistency according to applicable regulatory requirements, standard operating procedures (SOPs), processes and data standards
- Query generation and resolution to support the delivery of quality clinical data
- Performed external data reconciliation
- Responsible for ongoing review of data listings and creation/maintenance of study documentation
- Supported Data Management (DM) start-up activities across assigned trials, including electronic Case Report Form (eCRF) design and development of study documentation
- Supported database lock activities across assigned trials
- Identified trends in the data and possible solutions for efficiencies
- Performed extensive UAT testing of database
- Assist with data cleaning activities and data freezing during database lock
- Ensured the review of listings for quality, content, format, and output
- Reconcile 3rd party data with CDMS data.
Education
Bachelor’s Degree, BA, Linguistics -
University of Ibadan, Nigeria
11-2009
Skills
- Proficient with multiple EDC systems including Rave, Inform, Advantage eClinical, Jira, Gemini, Oracle Clinical, Medrio, ClinPlus, DSG, Veeva, J Review
Affiliations
Member Society for Clinical Data Management (SCDM)
Therapeutic Experience
Oncology, Cardiovascular, Respiratory, Neurology, Infectious Diseases, Vaccines
References
References available upon request.
Timeline
Clinical Data Manager
The Emmes Company
05.2021 - 01.2024
Clinical Data Manager
Integrium Clinical Research
02.2019 - 04.2021
Clinical Data Coordinator
Syneos Health (Contractor)
02.2018 - 01.2019
Bachelor’s Degree, BA, Linguistics -
University of Ibadan, Nigeria
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