Abigail Ademuwagun
Toronto,ON
Summary
7 Years’ experience in clinical research spread across 6 therapeutic areas (Oncology, Neurology, Cardiovascular diseases, Hematology, Endocrinology and Infectious diseases). Proficient in managing trials spanning Phases I to IV clinical trials, encompassing first-in-human Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, dose-ranging investigations, pivotal randomized controlled trials, as well as both single/double-blinded and unblinded studies. Skilled in executing study protocols according to ICH/GCP, TCPS CORE-2022 principles, GVP, GDP and ALCOA++ guidelines. Competent in electronic medical record systems (EMR) systems and electronic trial master file (eTMF). I have achieved a notable 25% reduction in project delays in clinical (translational genomics) research by skillfully managing task assignment, project deliverables, stakeholder communication and activity scheduling.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Associate Project Manager
Covenant University, Ota
Ota, OG
11.2017 - 12.2017
- University Centre for Research, Innovation and Discovery (CUCRID) and LASUTH
- Improved project monitoring and team coordination by 20% by developing clinical project plans such as project deviation plan, project schedules, communication plans, recruitment and retention plans
- Strategically Planned Projects, Initiated and executed implementation of Agile methodologies, resulting in improvement in project timelines
- Improved project knowledge sharing by 25% through use of Google Workspace
- Optimized Budgets and Controlled Costs; Successfully managed project budgets, reducing costs by 10% through effective resource allocation and negotiation with vendors
- Implemented real-time budget tracking with Microsoft Project, leading to reduction in financial discrepancies
- Reduced screen failures and ethical concerns by 50% by managing subject recruitment, prescreening, screening, sample collection and facilitation of Informed Consent process
- Led patient safety and regulatory compliance meetings for prompt reporting of Adverse Events (AE) and Severe Adverse Events (SAE) at clinical sites
- Led development of site SOPs and trained new study staff on GCP and study protocol
- Reduced project startup delays by spearheading cross-functional team meetings, activity scheduling and periodic progress update meetings
- Ensured quality assurance and compliance with study requirements by collaborating with team to review and understand clinical study documents such as study protocols
- Guaranteed efficient site monitoring by preparing site for various monitoring visits, such as Site Selection Visits (SSVs), SIVs, Interim Monitoring Visits (IMVs), Clinical Conduct Observation Visits (CCOV), and Close Out Visits (COV)
- Expedited study start-up and progress by 20% by supervising Institutional Review Board (IRB) and regulatory documents submission
- Collaborated with sponsor and CRA for study success, reviewed follow up letters, implemented needed action items and filed study documents into Institution site file using filing index
- Managed logistics for investigational products, overseeing shipment tracking and maintaining precise inventory records
- Collaborated to generate study project progress reports for review by principal investigator and site managers
- Conducted and facilitated meetings, formulated agendas, and circulated minutes for effective communication among project stakeholders.
- Partnered with project team members to identify and quickly address problems
- Delivered high level of service to clients to both maintain and extend relationship for future business opportunities
- Maintained tactical control of project budgets and timelines to keep teams on task and achieve schedule targets
- Supported senior managers and department leaders by completing projects and problem resolution under tight budgets and schedule demands
- Mentored and guided staff to enhance performance and exceed customer expectations
- Generated weekly and monthly status reports for helpful progress tracking
- Planned, monitored and analyzed project costs to meet financial goals
- Documented project progress to fulfill project requirements and establish traceability
- Negotiated contracts and agreements with vendors for constructive supplier relations
- Developed and maintained project documentation for reliable records
- Devised and implemented attainable schedules, timelines and milestones for on-track projects
- Updated customers and senior leaders on progress and roadblocks
- Recruited and oversaw personnel to achieve performance and quality targets
- Led team meetings to assess project progress and plan appropriately to meet delivery targets
- Identified and resolved risks to minimize project disruption
- Monitored and tracked project metrics and collected data to share with project members
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts
- Developed and implemented project plans and budgets to ensure successful execution
- Facilitated workshops to collect project requirements and user feedback
- Sourced, vetted and managed vendors needed to accomplish project goals
- Monitored project progress, identified risks and took corrective action as needed
- Maintained open communication by presenting regular updates on project status to customers
- Reported regularly to managers on project budget, progress, and technical problems
- Tracked project and team member performance closely to quickly intervene in mistakes or delays
- Analyzed project performance data to identify areas of improvement
- Verified quality of deliverables and conformance to specifications before submitting to clients
Clinical Research Coordinator
Lagos University Teaching Hospital, LUTH
Lagos, NG
12.2016 - 10.2017
- Led timely entry of source data into eCRF/EDC, thereby improving data integrity and accuracy by 30%
- Led project start-up at site by tracking site-specific submissions to by Institutional Review Board (IRB) and monitoring approval timelines for all essential documents
- Improved communication efficiency and issue resolution by 50% by serving as key point of contact between sponsor/CRO and site
- Improved comprehensive site documentation (for future audits) by 40% by filing all monitoring visit follow-up letters, study documents, source data documents, ICFs, CRFs and training logs in investigator’s site file (ISF)
- Maintained 100% protocol adherence and team competence by organizing and conducting protocol training sessions during Site Initiation Visits (SIV)
- Compiled and reviewed essential documents, including study protocol, ICF and CRF, for submission and approval by IRB
- Accelerated study close-out efficiency and timely site payments by 40% by facilitating completion of all close-out processes, e.g.
- Addressing closing queries and managing return of investigational products (IP) according to study protocol.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Followed informed consent processes and maintained records
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets
- Maintained compliance with protocols covering patient care and clinical trial operations
- Collected data and followed research protocols, operations manuals, and case report form requirements
- Managed patient recruitment, informed consent process and data entry to support trial objectives
- Maintained accurate and up-to-date case report forms and source documents for traceability
- Gathered, processed, and shipped lab specimens
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy
- Prepared and maintained regulatory documents for clinical trial submissions
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies
- Reviewed referral information and kept track of intakes from various referral sources
- Complied with research protocols by providing ongoing quality control audits
- Monitored patient safety throughout clinical trials and reported any adverse events
- Developed and maintained accurate and up-to-date case report forms and source documents
- Monitored unit budget to meet financial objectives for spend rate and funding
- Facilitated focus group sessions with project patients
- Collected, evaluated, and modeled collected data
Clinical Research Assistant
AIDS Prevention
Lagos, NG
01.2016 - 11.2016
- Initiative in Nigeria (APIN)
- Reduced site’s data query backlog by 50% by following up with all queries from data management team, clinical project manager (CPM) and Clinical research associate (CRA) for necessary corrections
- Ensured 100% compliance with ICH-GCP guidelines by meticulously overseeing ISF and project records
- Managed project delays and scope creeps by 30% by monitoring essential project documentation and integrated change management, with focus on meticulous record-keeping
- Improved efficient data monitoring by 50% by tracking and overseeing Case Report Forms (CRFs) and source data, ensuring accurate and audit-ready documentation and applying ALCOA++ principles of good documentation practice
- Compiled research documents for Institutional Review Board (IRB) submissions, encompassing study protocols and investigator credentials, across multiple projects
- Ensured that all project milestones were captured accordingly and communicated to principal investigator periodically.
- Assisted with research protocol development
- Educated patients regarding all facets of clinical study participation
- Managed updates and input for patient information database
- Demonstrated advanced knowledge of federal regulatory compliance guidelines
- Gathered, processed, and shipped lab specimens
- Collected data and followed research protocols, operations manuals, and case report form requirements
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Managed patient recruitment, informed consent process and data entry to support trial objectives
- Maintained compliance with protocols covering patient care and clinical trial operations
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies
- Followed informed consent processes and maintained records
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets
- Collected pertinent data and calculations to aid physician in interpreting results
- Answered telephone calls to offer office information, answer questions, and direct calls to staff
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy
- Monitored patient safety throughout clinical trials and reported any adverse events
- Developed and maintained accurate and up-to-date case report forms and source documents
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations
- Prepared and maintained regulatory documents for clinical trial submissions
- Maintained accurate and up-to-date case report forms and source documents for traceability
- Measured patient spirometry
- Collaborated with medical and administrative personnel to maintain patient-focused, engaging and compassionate environment
- Updated inventory, expiration and vaccine logs to maintain current tracking documentation
- Supported duties for diagnostic and technical treatment procedures, such as setting up and operating special medical equipment and apparatus
- Obtained and documented patient medical history, vital signs and current complaints at intake
- Liaised with patients and addressed inquiries, appointment requests and billing questions
- Prepared lab specimens for diagnostic evaluation
- Helped improve patient outcomes by educating and advising on relevant treatments and care
- Completed EKGs and other tests based on patient presentation in office
- Oriented and trained new staff on proper procedures and policies
- Taught patients about medications, procedures, and care plan instructions
- Conducted monthly and quarterly inventory of supplies using facility cost reporting records
- Explained procedures to patients to reduce anxieties and increase patient cooperation
- Implemented care and efficiency improvements to support and enhance office operations
- Collected and documented patient medical information such as blood pressure and weight
- Followed appropriate procedures to minimize patient's exposure to radiation
- Measured patient pulse oximetry
- Assisted with routine checks and diagnostic testing by collecting and processing specimens
- Assisted with research protocol development.
- Educated patients regarding all facets of clinical study participation.
- Managed updates and input for patient information database.
- Demonstrated advanced knowledge of federal regulatory compliance guidelines.
- Gathered, processed, and shipped lab specimens.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Followed informed consent processes and maintained records.
- Measured patient spirometry.
- Collaborated with medical and administrative personnel to maintain patient-focused, engaging and compassionate environment.
- Updated inventory, expiration and vaccine logs to maintain current tracking documentation.
- Supported duties for diagnostic and technical treatment procedures, such as setting up and operating special medical equipment and apparatus.
- Obtained and documented patient medical history, vital signs and current complaints at intake.
- Liaised with patients and addressed inquiries, appointment requests and billing questions.
- Prepared lab specimens for diagnostic evaluation.
- Helped improve patient outcomes by educating and advising on relevant treatments and care.
- Completed EKGs and other tests based on patient presentation in office.
- Oriented and trained new staff on proper procedures and policies.
- Taught patients about medications, procedures, and care plan instructions.
- Conducted monthly and quarterly inventory of supplies using facility cost reporting records.
- Explained procedures to patients to reduce anxieties and increase patient cooperation.
- Implemented care and efficiency improvements to support and enhance office operations.
- Collected and documented patient medical information such as blood pressure and weight.
- Followed appropriate procedures to minimize patient's exposure to radiation.
- Measured patient pulse oximetry.
- Assisted with routine checks and diagnostic testing by collecting and processing specimens.
- Collected pertinent data and calculations to aid physician in interpreting results.
- Answered telephone calls to offer office information, answer questions, and direct calls to staff.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Education
Ph.D. - Biochemistry
Covenant
Ota, NG10.2023
Master of Science - Biochemistry
University of Lagos
Lagos NG06.2017
Bachelor of Science - Biochemistry
Covenant University
OTA, NG07.2014
Skills
- Clinical project management:
- Microsoft project, JIRA, Trello, Agile methodologies (Scrum, Kanban, Sprint Planning)
- Clinical Trial Management Systems (CTMS): Medidata CTMS, Oracle Siebel CTMS, Veeva Systems
- Electronic Data Capture (EDC) Systems: Medidata Rave, Oracle Clinical
- And Documentation skills:
- Microsoft Word, ALCOA principles, Office 365, Google docs, IBM SPSS, Strong IT skills, in particular MS Excel
- Site Management and Monitoring: Medidata Rave, Oracle Siebel CTMS
- Risk and Quality Management: Risk Identification, Risk Analysis, Risk Mitigation, Quality Assurance & Control, Six Sigma
- Stakeholder Management: Communication Plans, Stakeholder Analysis, Status Reports
- Budget Management: Cost Estimation, Budget Tracking, Earned Value Management (EVM)
- Knowledge of regulatory landscape: Knowledgeable of regulatory requirements of the FDA and Health Canada such as ICH-GCP, FDA Form 1572, and QIU
- Soft skills: Strong communicator, ability to multi task and work effectively under pressure, collaborative mindset, exceptional organizational, communication skills, attention to details and multi-tasking
Certification
Regulatory Compliance and Informed Consent Process: Veeva Vault QMS: DocuSign, Adobe Sign, Veeva Vault eTMF.
Clinical Data Management: Medidata Rave, Oracle Clinical, SAS Clinical Data Integration.
Clinical Study Reports (CSRs
Languages
English
Full Professional
French
Elementary
Timeline
Associate Project Manager
Covenant University, Ota
11.2017 - 12.2017
Clinical Research Coordinator
Lagos University Teaching Hospital, LUTH
12.2016 - 10.2017
Clinical Research Assistant
AIDS Prevention
01.2016 - 11.2016
Ph.D. - Biochemistry
Covenant
Master of Science - Biochemistry
University of Lagos
Bachelor of Science - Biochemistry
Covenant University
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