Summary
Overview
Work History
Education
Skills
Additional Information
Timeline

Olusegun Adegoke

Summary

Focused on applying strong research skills toward improving data management, organization and reporting. Solid background with Pharmaceutical, Diagnostics, Academia companies and to learn new systems, processes and procedures quickly to maximize contributions. Highly collaborative and goal-oriented.

Overview

20
20
years of professional experience

Work History

Head, Data Management

USC, Alzheimer's Therapeutic Research
San Diego, CA
05.2018 - Current
  • Provide leadership and guidance to the data management group
  • Oversee a group of Data Managers, Data Analysts and Analytical developer
  • Participate in the protocol development, Database Launch, maintenance, and Freeze/Lock
  • Approve study documentation
  • Monitor quality and efficiency across projects to identify trends and opportunities for improvements
  • Management of Imaging files such as PET, CT and audio files
  • Use Teamwork project software to manage multiple projects and programs
  • Provide technical advice and solutions with internal and external stakeholders to solve problems and improve efficiency
  • Attend and present at vendor meetings
  • Create SOPs and Work instructions
  • Lead departmental continuous process development and initiatives
  • Review Data Management Plan, eCRF guidance, database edit check specifications
  • Worked closely with the clinical operation team: Biostat, Monitor, project managers, and Principal
  • Investigators
  • Identify sources of new technologies and/or systems to meet organizational goals and business strategies
  • Lead DM implementation team
  • Alignment of internal system to CDISC SDTM and CDASH
  • Manage relationships with internal and external stakeholders at both the project team level and with functional groups
  • Regular team debrief to celebrate successes and failures
  • Project Management
  • Oversight of data management vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
  • Oversight of build, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements
  • Define, implement, and maintain eCRF standards (CDASH), data capture conventions and CDISC compliant output for statistical analysis
  • Perform DM audit on department document
  • Strategic resource planning
  • Collaborate with strategic partners (Academia, Pharma, Biotech and CROs)
  • Attend professional conferences and training such as CDASH and SDTM training
  • Provide expert review and guidance for the production of Data Management deliverables including eCRF (case report form), database design and set-up, validation definition and programming, Data
  • Management Plan, and database deliverables to internal and external stakeholders
  • Ensure that staff is educated and compliant with current operating procedures and work instructions and project scope of work
  • Define and implement training/professional development strategy for Functional Department
  • Mentor staff members to develop a Data Management process, system, and drug development expertise.

Senior Clinical Lead Data Manager

Roche
Tucson, AZ
07.2016 - 11.2017
Spotfire
  • Functions as Lead Data Manager for assigned projects, acting as the primary point of contact for clinical data management issues for the study team
  • Uses knowledge of clinical data management to define data flow for assigned projects
  • Identifies and implements updates to study-specific processes as needed
  • Creates or oversees creation of data management documentation for assigned projects, including the Case Report Form (CRF), Data Management Plan (DMP), and clinical database specifications
  • Maintains robust documentation to ensure and/or document regulatory compliance always
  • Identifies and implements updates to documentation as needed
  • Uses knowledge of database management to define clinical database requirements
  • Performs user acceptance testing of clinical database and edit checks
  • Provides study-specific data entry training to data entry staff
  • Oversees data entry staff to ensure data quality
  • Performs clinical study data review as required by the DMP
  • Identifies incomplete, erroneous, and/or discrepant data and uses discretion to resolve issues
  • Identifies and manages data trends
  • Manages data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely manner as part of the study team
  • Uses professional judgment to escalate issues appropriately
  • Updates clinical database based on queries, data clarification forms, discrepancy management guidelines, and performs other database changes as necessary for a study
  • Maintains proficiency in use and analysis of clinical database system(s) and overall awareness of clinical data management practices by reading related literature, attending training classes and professional meetings, and participating in project-specific training
  • Works closely with IVRS, biomarker labs, and pharma partners in companion diagnostics
  • Uses Medrio EDC for Interlaboratory Reproducibility studies
  • Uses Tableau for data visualization and reporting, supports Marketing, Clinical Operation, management as needed for data visualization reporting.

Senior Data Manager

Roche Product
Welwyn Garden City
09.2007 - 07.2016
pharmaredefined Scripts
  • Knowledge and understanding of current industry standards (CDISC, SDTM)
  • Team Management experience:
  • Skills development for data management personnel in Welwyn and India
  • Hiring and mentoring new data managers
  • Technical problem and conflict resolution
  • Training and process development.

    • Quality Assurance Analyst

    GLP/GMP, GlaxoSmithKline
    11.2005 - 03.2007
    • Data/document review and sample & batch tracking using LIMS, SAP/R3
    • Used HPLC/Karl Fischer/UV/pH meter/IR spec/ micro-balance for drug analysis
    • Trend analysis and presentation of findings
    • Part of a team that implemented CAPA and analyzed root causes
    • Other employment

    Antimicrobial Analyst

    Government Chemist UK, Laboratory for Government Chemist UK
    09.2004 - 10.2005
    • Sample analysis and result reporting to client

    Clinical Data processor

    Quest Diagnostics UK
    01.2004 - 07.2004
    • Clinical trial sample processing
    • Data entry into Topcat database

    Education

    ICF Associate Certified Coach (ACC) - ICF Coaching

    University of Southern California, Los Angeles, CA
    09.2023

    MSc - Management Science

    University of Hertfordshire
    01.2007

    Bachelor's - Pure and Applied Chemistry

    Ladoke Akintola University of Technology
    09.2002

    Skills

    • Database Management, data entry, Rave, Jira, Medrio, Tableau, Spotfire (14 years)
    • Microsoft office, leadership, strategic planning (14 years)
    • STDM
    • Relationship Building
    • Team Leadership
    • Persuasive Approach
    • Employee Training
    • Teamwork and Collaboration
    • Coaching
    • Conflict Resolution
    • Decision Making
    • Training and Coaching
    • User Acceptance Testing
    • Co-Char, SCDM Academia Committee
    • R
    • Data Management
    • Technical Writing
    • Staff Development

    Additional Information

    InterlaboratoryTopcatIxRSAkintola Star Award Nov 2019

    Timeline

    Head, Data Management - USC, Alzheimer's Therapeutic Research
    05.2018 - Current
    Senior Clinical Lead Data Manager - Roche
    07.2016 - 11.2017
    Senior Data Manager - Roche Product
    09.2007 - 07.2016
    Quality Assurance Analyst - GLP/GMP, GlaxoSmithKline
    11.2005 - 03.2007
    Antimicrobial Analyst - Government Chemist UK, Laboratory for Government Chemist UK
    09.2004 - 10.2005
    Clinical Data processor - Quest Diagnostics UK
    01.2004 - 07.2004
    University of Southern California - ICF Associate Certified Coach (ACC), ICF Coaching
    University of Hertfordshire - MSc, Management Science
    Ladoke Akintola University of Technology - Bachelor's, Pure and Applied Chemistry

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    Olusegun Adegoke