Wayne McCullers
Apex,NC
Summary
Wayne McCullers is a Safety Database Administrator with over 16 years of experience in the clinical trial industry. While starting off in the Pharmacovigilance (Safety) area of the clinical research industry, he has also worked within the Study Start-up phase of clinical trials. He is committed to making sure that the FHI Clinical safety databases are maintained and provide adequate storage for studies and products. In 2007, Wayne commenced his career in the field of Clinical Research Organization (CRO) as a Safety Administrator at PVG. Subsequently, in 2011, he progressed his professional journey within the clinical industry by transitioning to the study start-up aspect of clinical trials. This transition provided him with the opportunity to engage in a larger number of database projects and act as a liaison with the Information Technology department, considering the growing implementation of databases. From 2011 to 2018, Wayne collaborated with various databases to store, support, and generate specific data for clinical trials. In 2018, Wayne returned to the PVG division of clinical trials to oversee and manage the Argus database for internal users and sponsors.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Safety Database Administrator
FHI Clinical
09.2023 - Current
- Support the day-to-day running of applications to sustain Drug Safety objectives, including without limitation Oracle Safety bases such as Argus Safety, Clinical One, Nukleus Safetybase, Viedoc, OpenClinica, MedDRA, WHO Drug Dictionary, and business intelligence tools.
- Assist with the configuration of safety database for products, studies, user privileges and workflow. Perform programming, validation, and front-end advance conditions (e.g., query sets, generation of custom reports for data analysis, routine, and ad hoc data extractions) to meet internal business requirements based on contracted timelines.
- Ensure all safety database activities are completed in accordance with SOPs and other applicable regulations and understand how regulatory changes (EMA/FDA) may impact the department.
- Take part in impact analysis of changes to Drug Safety Systems identifying the risks and benefits associated with the change. Keep management aware of potential and actual issues and integrate risk management.
- Review documentation associated with pharmacovigilance SOPs as related to the safety database.
- Act as liaison with IT and vendors to support release and/or patches delivery.
- Train, assist and support the Pharmacovigilance Team and other end-users as a System and Database Administrator for technical support.
- Assist in developing solutions for ongoing improved pharmacovigilance.
- Evaluate proposed project ideas / software changes through technical impact analysis and estimated business value to contribute to decision-making.
- Manage safety system access requests (internal and external).
- Maintain up-to-date knowledge of regulatory requirements for safety reporting as it relates to the safety database.
- Manage safety database upgrades and change control processes.
- Provide guidance on additional projects as needed.
- Perform other tasks as may be required and agreed to from time to time.
Senior Safety Systems Specialist
IQVIA BIOTECH
06.2020 - 09.2023
- User maintenance.
- Study design.
- E2B exporting and importing.
- Aggregate reporting.
- Expedited Reporting.
- Periodic Reporting.
- Liaises with IT and Safety to facilitate timely resolution of system requests.
- Developed and maintained reports related to Safety; provided regular updates to Safety team members on status of reporting activities.
- Created and executed system validation.
- Led internal and client calls when Safety technical support as required; communicated technical information clearly and concisely to non-technical individuals.
- Prepared safety reports for submission to Sponsors, Regulatory Authorities, or Investigators.
- Performed project-related study close-out and archival tasks.
- Assisted management and/or Safety Management Lead in writing Standard Operating Procedures and developed documents related to intake/triage functions, including study specific processes.
- Assisted management in defining and implementing process improvement activities to increased efficiency within the Safety Management department.
- Mentored and/or trained new Safety staff.
- Performed other duties as assigned by manager.
- Maintained and further developed Content Management System (CMS).
Safety Systems Specialist I
IQVIA BIOTECH
01.2018 - 06.2020
- User maintenance.
- Study design.
- E2B exporting and importing.
- Aggregate reporting.
- Expedited Reporting.
- Supported the day-to-day running of applications to sustain Drug Safety objectives, including without limitation Argus Safety, Nukleus Safetybase, MedDRA, WHO Drug Dictionary, and business intelligence tools.
- Assisted with the configuration of safety database for products, studies, user privileges and workflow. Performed programming, validation, and front-end advance conditions (e.g., query sets, generation of custom reports for data analysis, routine, and ad hoc data extractions) to meet internal business requirements based on contracted timelines.
- Ensured all safety database activities were completed in accordance with SOPs and other applicable regulations and understand how regulatory changes (EMA/FDA) may impact the department.
- Liaised with IT and Safety to facilitate timely resolution of system requests.
- Developed and maintained reports related to Safety; provided regular updates to Safety team members on the status of reporting activities.
- Created and executed system validation.
- Led internal and client calls when Safety technical support was required; communicated technical information clearly and concisely to non-technical individuals.
- Prepared safety reports for submission to Sponsors, Regulatory Authorities, or Investigators.
- Performed project-related study close-out and archival tasks.
- Assisted management and/or Safety Management Lead in writing Standard Operating Procedures and developed documents related to intake/triage functions, including study specific processes.
- Assisted management in defining and implementing process improvement activities to increase efficiency within the Safety Management department.
- Mentored and/or trained new Safety staff.
- Performed other duties as assigned by the manager.
Site Recruitment Associate II
Premier Research
01.2017 - 06.2018
- Took independent responsibility for assigned site identification projects.
- Worked with study team for projects with increased protocol complexity, site numbers, plan to identify potential sites and/or customer SOPs or processes.
- Utilized historic site performance metrics, cluster sites, partner sites, Medical Informatics data, and other data to identify potential sites.
- Created and executed all Site Recruitment Questionnaires globally to support global trial Initiation.
- Maintained the Company Template Site Recruitment Questionnaire (SRQ).
- Created, delivered and obtains the SRQ from all PI's and/or sites for study participation consideration.
- Assisted in the design and implementation of all relevant systems including, but not limited to, the site identification metrics and reporting, surveys, etc.
- Created and maintained relationships with sites and obtained updated information at least on a yearly basis.
- Updated Investigator Database with information obtained during the site selection process as well as after studies have been completed.
- Submitted and reviewed investigators for quality assurance status as applicable.
- Tracked all project activities in the tracking system.
- Designed, distributed, tracked and reviewed Site Recruitment Questionnaires (SRQs) for completeness, site capability and availability based on project-specific requirements and needs.
- Provided project progress reports to Internal and External project teams including department management.
- Adhere to project timelines.
- Reviewed and tiers sites for contact based on historical site performance and other required criteria.
- Entered new sites and investigators into the Investigator Database, reviewed entries for duplicates.
- Responded to site questions about assigned studies in a timely manner.
- Collected information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
- Liaises with internal customers to review areas that impact study start-up. Shares Site Identification and Recruitment information with the project team.
- Worked within the scope of Clinical Management Plan (CMP), study processes, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
Feasibility Specialist
PPD
01.2016 - 06.2017
- Coordinated the execution of non-billable and billable feasibility studies and site prioritization, and interacted with global clinical and project management teams.
- Contributed to the delivery of feasibility reports and site recommendations which were provided as client deliverables and served to assist PPD in understanding potential therapeutic and delivery enrollment challenges and to win new business.
- Participated, as requested, in clinical intelligence-gathering initiatives as alternatives to survey-driven feasibility assessments.
- Assisted Clinical Management to expedite feasibility, site selection and study start-up.
- Ensured all privacy legislation and policies were followed.
- Participated in process improvement initiatives for Feasibility & Site Identification.
Safety Administrator II
PPD
10.2015 - 02.2016
- Provided administrative support to the Post-Approval Pharmacovigilance Department for global and domestic clinical trials.
- Participated in safety database entry, quality control, report distribution, program file creation and maintenance, and document management for assigned studies.
- Effectively communicated with program team members and client contacts.
- Responsible for adhering to PPD's corporate policies and SOPs/WPDs.
Safety Administrator II
PPD
01.2015 - 01.2016
- Provided administrative support to the Post-Approval Pharmacovigilance Department for global and domestic clinical trials.
- Participated in safety database entry, quality control, report distribution, program file creation and maintenance, and document management for assigned studies.
- Effectively communicated with program team members and client contacts.
- Responsible for adhering to PPD's corporate policies and SOPs/WPDs.
US Site Intelligence Analyst I
Parexel International
10.2011 - 09.2014
- Analyzed investigative site lists to ensure investigator compliance, data completeness.
- Programmed PAREXEL Survey in support of feasibility, pre-qualification, Site Intelligence.
- Responsibilities also included the creation of PAREXEL Survey, and support on other systems, and tools during feasibility and prequalification processes.
- Analyzed reports to identify deficits in PAREXEL's pool of qualified investigators.
- Maintained and uploaded qualified investigators within the company's database.
- Completion of all assigned helpdesk tickets.
Operations Coordinator II (Team Lead)
Quintiles (IQVIA)
10.2010 - 10.2011
- Assisted in the processing of Lifecycle Safety data by collecting and tracking incoming Adverse Events (AE)/endpoint information.
- Assisted with project workflow including database entry, quality control activities, and generation of Lifecycle Safety data reports and preparation of Lifecycle Safety submission dossiers.
- Assisted with deadline quality measurements, as directed by operations team member or Manager.
Safety Administrator I, Safety Administrator II
PPD
04.2007 - 07.2010
- Provided administrative support to the Pharmacovigilance Department for global and domestic clinical trials.
- Worked with Safety Specialist to ensure the quality of documentation and timeliness of deliverables was achieved.
- Trained and mentored junior Safety Administrators for the department.
- Performed data entry of site-specific information from SAE report forms into safety databases as well as Access and Excel tracking databases.
- Participated in quality control, report distribution, project file creation and maintenance for assigned studies.
- Provided backup IIC safety support by answering the safety hotline phone, triaging incoming investigator site documents and distributing information to the assigned project staff.
- Assisted in the audit readiness process for assigned studies and with the preparation of materials for internal and Client audits.
- Responsible for adhering to PPD's corporate policies and SOPs/WPDs.
- Assisted with project start-up and close-out activities including archival of documents.
Education
Associate degree - Computer Technology
East Coast Polytechnic Institute ECPI
Raleigh, NC, United States01-2003
BA - Business Administration/Management
Saint Leo University
Saint Leo, Florida, United States03-2026
Skills
- Database management
- Backup and recovery
- Database monitoring
- Database troubleshooting
- Database administration
- Systems administration
- System testing
Certification
- 2023, GCP for Clinical Trials with Investigational Drugs and Biologics
- 2023, Biomedical Researchers
- 2023, Conflict of Interest
- 2023, Information Privacy and Security
- 2023, Responsible Conduct of Research
Languages
English
Timeline
Safety Database Administrator
FHI Clinical
09.2023 - Current
Senior Safety Systems Specialist
IQVIA BIOTECH
06.2020 - 09.2023
Safety Systems Specialist I
IQVIA BIOTECH
01.2018 - 06.2020
Site Recruitment Associate II
Premier Research
01.2017 - 06.2018
Feasibility Specialist
PPD
01.2016 - 06.2017
Safety Administrator II
PPD
10.2015 - 02.2016
Safety Administrator II
PPD
01.2015 - 01.2016
US Site Intelligence Analyst I
Parexel International
10.2011 - 09.2014
Operations Coordinator II (Team Lead)
Quintiles (IQVIA)
10.2010 - 10.2011
Safety Administrator I, Safety Administrator II
PPD
04.2007 - 07.2010
BA - Business Administration/Management
Saint Leo University
Associate degree - Computer Technology
East Coast Polytechnic Institute ECPI
Summary Of Qualifications - Description
Wayne McCullers is a Safety Database Administrator with over 16 years of experience in the clinical trial industry. While starting off in the Pharmacovigilance (Safety) area of the clinical research industry, he has also worked within the Study Start-up phase of clinical trials. He is committed to making sure that the FHI Clinical safety databases are maintained and provide adequate storage for studies and products. In 2007, Wayne commenced his career in the field of Clinical Research Organization (CRO) as a Safety Administrator at PVG. Subsequently, in 2011, he progressed his professional journey within the clinical industry by transitioning to the study start-up aspect of clinical trials. This transition provided him with the opportunity to engage in a larger number of database projects and act as a liaison with the Information Technology department, considering the growing implementation of databases. From 2011 to 2018, Wayne collaborated with various databases to store, support, and generate specific data for clinical trials. In 2018, Wayne returned to the PVG division of clinical trials to oversee and manage the Argus database for internal users and sponsors.
Research Therapeutic Experience
- Oncology, 10, Lymphoma Phase (II), Kidney Cancer Phase (I), Pancreatic Cancer Phase (II)
- Dermatology, 2, Atopic Dermatitis Phase (III)
- Musculoskeletal, 8, Rheumatoid Arthritis Phase (II)
- Nervous System, 2, Parkinson's Phase (I)
- Schizophrenia, 2, Phase (I)
- Respiratory, 2, Allergic Rhinitis (II)
- Endocrinology, 6, Diabetes Phase (I, II, III)
- Hyperplasia, 2
- Cardiovascular, 2, Phase III. (Hypertension, Stroke, Angina): Phases II
Professional Development Experience
- 2020, Participated in Clinical Trials Research Associate - Core Competencies, under Durham Technical Community College
- 2018, Participated in Best Practices in Clinical Practice training courses under FHI Clinical
Country Experience
- Canada
- China
- Denmark
- Dominican Republic
- USA
Personal Information
Title: Safety Database Administrator