Phoebe Ayodele
Katy
Summary
Dynamic Senior Clinical Trial Manager with extensive experience at Merck Oncology, excelling in regional operations and global study execution. Proven track record in risk management and cross-functional team leadership, achieving a 30% improvement in patient enrollment. Adept at ensuring inspection readiness and maintaining data integrity throughout the clinical trial process.
Overview
18
18
years of professional experience
Work History
Senior Clinical Trial Manager
Merck Oncology
08.2024 - Current
- Led end-to-end clinical trial execution for oncology programs across North America, ensuring alignment with global timelines and BeiGene-like regional delivery expectations.
- Directed regional feasibility assessments, country allocations, and site selection processes in collaboration with Medical Affairs, Country Heads, and Feasibility Managers.
- Managed local adaptations of global study documents including Informed Consent Forms (ICFs) and ensured timely submission to IRBs/ECs across multiple jurisdictions.
- Oversaw regional CRA teams and reviewed monitoring reports to ensure protocol compliance, data quality, and site performance.
- Collaborated closely with Regulatory Affairs and Study Start-Up teams to ensure timely regulatory and ethics approvals.
- Maintained accurate regional entries in study systems and tools; led regular operations meetings with regional team members.
- Provided input into global clinical supply planning, including local label reviews and comparator drug status assessments.
- Partnered with Clinical Business Operations to manage investigator fees, site payments, and patient travel reimbursements within budget constraints.
- Ensured inspection readiness for all regional sites and supported audit response activities and CAPA implementation.
- Reviewed and contributed to key study documentation including protocols, CRFs, and Clinical Study Reports (CSRs).
- Monitored regional resource utilization and provided feedback for team performance evaluations and mentoring of junior staff.
Clinical Trial Manager
AstraZeneca Oncology (via Parexel as CRO)
02.2022 - 08.2024
- Spearheaded regional operations for multi-country oncology trials, coordinating with internal and external stakeholders to deliver studies on time and within budget.
- Developed and managed recruitment and retention strategies that improved patient enrollment by 30%, leveraging best practices applicable to rare disease populations.
- Served as primary liaison between sponsor and CRO partners, overseeing over $10M in contracted services and reducing overhead costs by 10% through efficient vendor management.
- Conducted protocol reviews and operational refinements to enhance site feasibility and reduce start-up timelines by 25%.
- Implemented risk mitigation strategies that reduced protocol deviations and non-compliance events by 35%.
- Coordinated regional TMF QC activities and ensured site-level documentation was maintained per study plan.
- Worked with Medical Writing and Global Clinical Study Managers to support CSR preparation and finalization.
- Led lessons learned sessions post-study closeout, contributing to SOP updates and operational efficiencies across future trials.
Clinical Trial Manager
PPD
02.2020 - 02.2022
- Organized and managed clinical trials in compliance with ICH-GCP guidelines.
- Conducted site selection, initiation visits, monitoring visits and closeout visits as required by the protocol.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Reviewed study documents for accuracy, completeness and regulatory compliance.
- Provided direction to external vendors such as CROs regarding protocol development, case report forms design, data management systems.
- Developed and implemented clinical trial management plans, protocols and reports.
Senior Clinical Research Associate
Premier Research (CRO)
01.2017 - 02.2020
- Conducted comprehensive site monitoring visits (selection, initiation, monitoring, and close-out) across oncology and metabolic disease trials.
- Trained and mentored junior CRAs, resulting in a 25% improvement in audit outcomes and protocol adherence.
- Maintained >98% protocol compliance at monitored sites through rigorous oversight and proactive issue resolution.
- Managed site budgets and financial reporting, maintaining variance within 5% threshold.
- Collaborated with investigators and site staff to ensure ethical standards and regulatory requirements were met during participant recruitment and consent.
- Reviewed and submitted over 40 regulatory filings with a 95% first-time acceptance rate.
- Identified and resolved potential risks early, reducing delays by 25% and improving overall trial progression speed.
Clinical Research Associate (CRA)
Clinilabs
04.2010 - 03.2013
- Monitored Phase II and III oncology and CNS trials, achieving a 99% compliance rate across all monitored sites.
- Acted as primary liaison between sponsor and investigative sites, facilitating communication and streamlining protocol execution.
- Reduced data discrepancies by 30% through enhanced source data verification and training initiatives.
- Supported regulatory submissions and inspections, contributing to successful audits and minimal findings.
- Assisted in the development of standard operating procedures and training materials for new CRAs.
Study Coordinator
Memorial Hermann
03.2007 - 04.2010
- Coordinated daily operations of oncology and cardiovascular clinical trials at the investigational site.
- Managed participant recruitment, informed consent process, and study documentation.
- Maintained strict confidentiality and security of patient data.
- Supported principal investigators in protocol execution and regulatory compliance.
Education
Master of Business Administration (MBA) -
American InterContinental University
Houston, TX01.2013
Bachelor of Science (BSc.) - Biological Sciences
University of Benin
Nigeria01.2007
Skills
- Regional Clinical Operations Leadership
- Global Study Planning & Execution
- ICH-GCP
- FDA
- Local Regulatory Compliance
- EC/IRB Submissions
- Inspection Readiness
- Vendor Oversight
- CRO Oversight
- Budget Management
- Resource Planning
- Protocol Development
- Feasibility Assessments
- Site Selection
- Start-Up Process Optimization
- Risk Management
- CAPA Implementation
- Data Integrity
- Query Resolution Oversight
- TMF Maintenance
- Quality Assurance
- Cross-Functional Team Leadership
- Clinical Supplies Coordination
Personal Information
Title: Clinical Trial Manager
Therapeutic Expertise
Solid Tumors, Breast Cancer, Liquid Tumors, Myelofibrosis, Hypothyroidism, Polycystic Ovary Syndrome (PCOS), Cardiovascular Comorbidities in Oncology Patients, Diagnostic Kits, Cardiac Monitoring Tools
Timeline
Senior Clinical Trial Manager
Merck Oncology
08.2024 - Current
Clinical Trial Manager
AstraZeneca Oncology (via Parexel as CRO)
02.2022 - 08.2024
Clinical Trial Manager
PPD
02.2020 - 02.2022
Senior Clinical Research Associate
Premier Research (CRO)
01.2017 - 02.2020
Clinical Research Associate (CRA)
Clinilabs
04.2010 - 03.2013
Study Coordinator
Memorial Hermann
03.2007 - 04.2010
Master of Business Administration (MBA) -
American InterContinental University
Bachelor of Science (BSc.) - Biological Sciences
University of Benin
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