CLINICAL OPERATIONS & STUDY MANAGEMENT
PERSONAL PROFILE
- 10 years of global study management experience.
EXPERTISE
Global Study Management; Vendor Selection and Oversight; Project, Budget, and Time Line Management; Issue Management; Team Leadership and Training; Site Identification and Selection; Enrollment Models; Clinical Supply Planning; Investigator/Vendor Meetings; Monitoring Plans; Study Forms (Consent Forms, Trial Master File, EDC/Case Report Forms, and Clinical Study Reports); IxRS Systems; Data Review, Cleaning, and Database Lock; Study Therapeutic Areas of Expertise: Analgesia/Anesthesiology, Gastroenterology, Hepatic Disorders, Immunology, Infectious Diseases, Inflammatory Diseases, Oncology, Skeletal Diseases, Respiratory, Pediatrics, and Neurology.
PROFESSIONAL EXPERIENCE
Clinical Trial Manager, Takeda Pharmaceutical Company
Executed clinical studies according to global regulatory requirements (US CFR, EU CTD, and ICH GCP), SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP). Provided study level updates, including time lines and budget, to cross-functional Clinical Program Team (CPT), ensuring that study issues and proposed solutions were escalated to the CPT. Led cross-functional Study Execution Team to ensure study goals were met on time and within budget. Managed study budget, including Task Orders and Change Orders. Led evaluation and selection of vendors, including contract and budget negotiation, invoice approval, and financial reconciliation process. Oversaw day-to-day work of vendors (setting expectations, training, managing time lines and deliverables, and issue management, including escalating medical issues to appropriate medical personnel). Provided Clinical Operations input to other study activities: site identification and selection; enrollment models; clinical supply planning and drug supply; organization of investigator and vendor meetings; development of informed consent forms; management of Trial Master File; development of monitoring plans, IxRS systems, and EDC/Case Report Forms; data review and cleaning, as well as database lock; and writing of Clinical Study Report. Collaborated to identify risks to the study and suggest risk mitigation plans.
Senior Oncology Clinical Trial Manager, Amgen
Managed global clinical trials from study start-up to close-out, as primary study contact. Ensured study conduct met SOPs, ICH/GCP Guidelines, and local regulations. Managed study budget, time lines and insourcing/outsourcing partners. Contributed to study concept, protocol, clinical study report, and other critical study documents. Managed vendors, including selection, negotiation, implementation, and management of Statements of Work/Scope of Work (SOW). Identified, resolved, or escalated issues with time lines and deliverables. Coordinated and managed study resources, including staffing. Collected, tracked, and reported established Key Performance Indicators (KPIs): query resolution, AE/SAE data collection, drug reconciliation/shipment, site and patient enrollment, etc. Provided effective management of all protocol deviations/violations to ensure proper documentation and worked with Investigative sites to reduce occurrence.
Senior Oncology Study Manager/CRA (Consultant)/Data Review Manager, BioVex
Performed management of study site activities to ensure integrity of clinical data, as per regulatory guidelines, SOPs, and Project Specific Operating Procedures (PSOPs). Provided on-site oncology monitoring during critical analysis deadlines, including oversight of consultant field monitors. Completed project activities associated with monitoring functions of Phase 3 adult oncology clinical research studies. Provided clinical and technical support for CRA I and administrative staff. Helped develop clinical data review plan, guided team providing clinical review of data, and collaborated in high-level review of data requiring medical/clinical expertise.
Additional Related Experience
- Member of US Senate Cancer working group
- Member of FDA Pediatric Oncologic Drug Advisory Committee