Ayoola Ajele-Lawrence
Glenwood
Summary
Years of Technical and Clinical Labeling and Supply Management experience, providing subject matter expertise on global clinical trials while maintaining 100% compliance with regulatory requirements.
Skilled specialist with proven track record in delivering impactful results. Adept at team collaboration and flexible in adapting to changing needs, in the health care industries and consistently driving successful outcomes. Known for reliability and strong focus on achieving objectives.
Overview
14
14
years of professional experience
Work History
Snr Specialist, Clinical Labels
Abbvie Inc
02.2018 - Current
- Managed the Development, review, approval and maintenance of clinical trial labels in compliance with regulatory requirements, study protocols and company standards.
- Reviewed label content for accuracy, including protocol numbers, dosage instructions, storage conditions, subject identifiers and regulatory statements.
- Ensured compliance with global regulations, including FDA, EMA, ICH-GCP, and country specific label requirements.
- Coordinated label change controls, revisions, translations, and implementation activities through the clinical trial lifecycle, and support investigational product packaging and label activities for Phase I-IV Clinical studies.
- Conducted quality checks and risk assessments to minimize labeling errors and maintain inspection readiness, managed label documentation, approval of workflows and record within electronic document management systems.
- Participated in audits and regulatory inspections, providing labeling documentation and subject matter expertise, developed and improved labeling processes, standard operating procedures (SOPs), and training materials to enhance operational efficiency and compliance.
- Coordinated implementation of multilingual labels across functional international study sites, ensuring on-time study startup and works with modules such as CSS (HUB), Frozen Scheduling, Clinical Veeva Vault, SaaS GxP inventory, Smartsheet, QuickSign, Citrix (PPSD), Tesla, etc.
Clinical Research Specialist
Community Health Network
01.2017 - 01.2018
- Support and coordinate clinical research studies in compliance with study protocols, GCP, ICH, FDA regulations and institutional policies.
- Assisted with study start-up activities, including regulatory submissions to sites initiation and investigator documentation.
- Assisted with administrative activities, including screening associated with conduct of clinical trials and support of participant while ensuring proper informed consent procedures.
- Collect, process, review and maintain accurate clinical trial data and source documentation and monitor, perform regulatory audits and routine meetings as needed.
- Monitored participant safety, adverse event & effect precautions.
Technical Support
Delta Technical Solutions
08.2016 - 01.2017
- Provided first and secondary levels of technical support for hardware, software, network and application related issues and diagnosed technical issues, providing resolution-based support.
- Configured, installed and maintained computer systems, including upgrading software, providing remote access and ticketing system/peripheral devices.
- Managed and tracked support requests using help desk and ticketing management system to ensure timely resolution.
- Assisted users with password resets, account management, and system access issues, documented troubleshooting procedures, solutions, and users’ guides to improve service efficiency.
- Escalated complex technical issues to appropriates teams and followed u to ensure resolution, and support testing, quality checks to ensure optimal performance and user satisfaction.
- Supported Microsoft windows, Microsoft office 365, email systems, printers, mobile devices and network connectivity.
- Trained end users in software applications, security practices and technology-related processes and help resolved high volume of technical support tickets, while maintaining excellent customer satisfaction ratings.
CILA House Support Manager
Alliance Health Care Inc
10.2014 - 08.2016
- Supervised daily operations of the residence during week and weekend hours, including staff scheduling, resident care and safety protocols.
- Lead and mentor caregiving staff ensure delivery of high-end quality with assisted living and memory care services aligned with individualized care plans.
- Oversee medication administration and monitor health status of residents with complex needs such as Alzheimer's and dementia.
- Coordinate with healthcare professionals, social workers, and families to develop and update personalized care plans that promote resident independence and wellbeing.
- Manage operational tasks including budgeting, inventory control, and maintaining compliance with health regulations and safety standards.
- Facilitate a positive environment by encouraging teamwork, communication, and resident engagement activities.
- Address any emergent issues promptly, ensuring resident safety while maintaining a calm and professional demeanor.
Clinical Epic Go-live Support
Community Health Network
04.2012 - 02.2014
- Participated in Epic Ambulatory/Cadence and provided at-the-elbow support to physicians, nurses and clinical staff during Epic system go live implementations.
- Assisted end users with Epic workflows, navigation, documentation, order entry and troubleshooting and also help to identify workflow issues to appropriate support team for resolution.
- Delivered real-time training and guidance to improve user adoption and system efficiency, while collaborating with clinical, operational and IT teams to ensure a smooth transition to Epic electronic health record (EHR).
- Maintained detailed records of support activities, issue resolution and end-user interactions, also supported compliance with organization policies, patient privacy, regulations and healthcare documentation standards.
- Support implementing team lead with clear instruction on how to navigate modules within the Epic Software and management electronic resources.
Education
Bachelor of Science -
Uniilorin Secondary School
NigeriaComputer Science - Computer Science
Moshood Abiola Polytechnic
06-1996
High School Diploma -
Uniilorin Secondary School
NigeriaSkills
- Customer relations
- Expert problem solving
- Analytical thinking
- Documentation management
- Advanced communication
- Quality assurance
- Management collaboration
- Quality assessment
- Supply management
Interests
Career Interests: Clinical Research, Clinical Supply Management, Validation, Clinical Trial Labeling
Timeline
Snr Specialist, Clinical Labels
Abbvie Inc
02.2018 - Current
Clinical Research Specialist
Community Health Network
01.2017 - 01.2018
Technical Support
Delta Technical Solutions
08.2016 - 01.2017
CILA House Support Manager
Alliance Health Care Inc
10.2014 - 08.2016
Clinical Epic Go-live Support
Community Health Network
04.2012 - 02.2014
Bachelor of Science -
Uniilorin Secondary School
Computer Science - Computer Science
Moshood Abiola Polytechnic
High School Diploma -
Uniilorin Secondary School