Kaycee Anoliefo
Houston,TX
Summary
Over 3 years of professional experience in pharmaceuticals and healthcare, focusing on clinical trial and project management across dermatology, neurology, and oncology. Proven expertise in managing multi-site studies and clinical operations from planning through execution. Strong proficiency in clinical project management tools such as Power BI, Salesforce, SharePoint, Smart Sheets, and clinical trial electronic data capture (EDC) systems like Medidata Rave, ensuring regulatory compliance and protocol adherence in clinical trials. Demonstrated ability to lead cross-functional teams, manage timelines, and ensure projects are delivered on time and within budget while meeting key performance indicators (KPIs) through the use of advanced project management systems. Skilled in regulatory submissions (IRB, ethics committee applications), clinical documentation, and maintaining compliance with FDA, EMA, and ICH-GCP standards, ensuring patient safety, data integrity, and accurate reporting. Effective communicator with experience in stakeholder collaboration, vendor management, and issue resolution, ensuring smooth trial progression and operational efficiency.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Project Manager (Lead Patient Care Specialist)
Specialty Health Network
12.2022 - Current
- Managed over 140 patients ensuring patients continue therapy uninterrupted through effective time management to meet daily metrics and prioritizing multiple tasks to meet deadlines and KPIs
- Managed and lead process improvement initiatives, resulting in an 80% improvement in operational efficiency by optimizing case load management and reducing backlog
- Managed a neurology and oncology patient support program, acting as a patient advocate to ensure patient safety and access to therapies while overseeing a caseload of over 140 patients
- Collaborate and build relationships with patients, caregivers, clinical professionals, and pharmaceutical companies to provide comprehensive patient support
- Utilized Power BI to track and improve team performance, generate KPIs, and present detailed analytics for management review, ensuring goals and deliverables were met on time
- Oversee accuracy and organization of patient files and documents ensuring accuracy and organization using Salesforce patient management software
- Collaborated with cross-functional teams, specialty pharmacies, and distribution partners to remove barriers to medication access, improving patient outcomes and maintaining budget constraints
- Developed strong rapport with both internal team members and external partners such as referring physicians or other healthcare professionals involved in a patient''s care plan.
- Improved patient outcomes by closely monitoring vital signs and promptly reporting any changes to medical staff.
- Assisted in the development of individualized care plans to address each patient''s unique needs and goals.
Project Coordinator (Clinical Research)
Probity medical research
12.2021 - 12.2022
- Conducted Phase I-IV dermatology clinical trials, following FDA and Health Canada guidelines, ensuring quality data collection and adherence to regulatory requirements
- Managed patient recruitment, screening, and enrollment, ensuring protocol adherence and accurate data reporting using Rave EDC
- Managed multiple study protocols, collaborating with sponsors and CROs to prepare and submit regulatory documents (i.e., amendments, informed consent forms, IRB application packages/submissions etc.)
- Created/updated source documents for clinical trials; Ensured timely and accurate transcription of information on source documents
- Monitored study compliance and maintained quality assurance through accurate and timely data reporting
- Monitored serious adverse events or reactions and reported immediately to Principal Investigator
- Followed-up on adverse events according to SOPs including filing reports with internal (REB), sponsors, external regulatory bodies and/or patients
- Collaborated with CROs and clinical teams to monitor site performance, collect data, and address compliance issues in alignment with study timelines, ensuring proactive management of study sites
- Gathered, processed, and shipped lab specimens.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Liaised between departments to facilitate communication and keep appropriate parties updated on project developments.
- Kept projects on schedule by managing deadlines and adjusting workflows.
- Assisted with onboarding newly hired staff members and coached on task prioritization.
- Managed competing demands and professionally adapted to frequent change, delays and unexpected events.
Clinical Project Management Associate
Probity Medical Research
12.2020 - 12.2021
- Managed multi-site dermatology clinical studies from planning through execution, focusing on site initiation, monitoring, and close-out activities ensuring timely completion of deliverables
- Coordinated with stakeholders such as sponsors, CROs, IRBs, and clinical trial sites to manage communications, ensuring recruitment targets and project timelines were met
- Tracked study milestones using Microsoft Smart Sheets to maintain project timelines and monitored patient recruitment and visits, protocol adherence, and adverse events reporting
- Track and reported on project progress, providing insights for team collaboration and improving trial management processes
- Managed local and central IRB applications, renewals, and study closeouts within established timelines, ensuring study documentation accuracy and regulatory compliance
- Ensured research sites/study team was trained on updated assigned study protocols
- Developed and oversaw the completion and accuracy of regulatory documents including protocols/amendments, informed consent forms (ICFs), FDA 1572s, source document worksheets
- Led training initiatives for research sites and ensured compliance with updated study protocols, enhancing data quality and site performance
Education
Honors BSc. - Chemistry/Biology
Wilfrid Laurier University
Waterloo, ON01.2022
Skills
- Project and Clinical Trial Management
- Cross-Functional Collaboration
- Regulatory Compliance
- Vendor and Stakeholder Management
- ICH-GCP Guidelines
- Metrics/KPI Generation and Analysis
- Risk and Issue Management
- Ethics & IRB submission
- Project Management Tools and EDC systems
- Client Relations
Certification
Google Project Management: Professional Certificate
Timeline
Project Manager (Lead Patient Care Specialist)
Specialty Health Network
12.2022 - Current
Project Coordinator (Clinical Research)
Probity medical research
12.2021 - 12.2022
Clinical Project Management Associate
Probity Medical Research
12.2020 - 12.2021
Honors BSc. - Chemistry/Biology
Wilfrid Laurier University
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