Emilie Jade Misajon
MSN, RN, CCRP
Rockaway,NJ
Summary
Masters-prepared and certified clinical research professional with extensive leadership experience in global and local clinical trial operations within the pharmaceutical industry and clinical research sites. Strong knowledge of FDA regulations and ICH GCP Guidelines, enabling effective training and supervision of diverse clinical trial personnel and research sites. Proven track record of identifying problem areas, designing programs, and implementing innovative projects to enhance the clinical trial experiences for patients and research sites. Also possesses a robust clinical nursing background with specialization in neuroscience and Intensive Care Unit (ICU) care.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Senior Global Trial Manager
Novartis Pharmaceuticals Corporation
05.2021 - 06.2024
- Led clinical trial team to ensure adherence to timelines, budgets, operational procedures, and quality standards in compliance with Good Clinical Practice (GCP)
- Managed operational deliverables, tracked study progress, and oversaw clinical project managers, data managers, vendors, and CROs
- Directed CRO and vendor selection, including RFP reviews, budget negotiations, and Transfer of Obligations documents
- Spearheaded protocol and informed consent form (ICF) development and amendments, providing operational insight into feasibility, timelines, and cost estimates
- Collaborated with cross-functional teams, serving as the primary contact for operational issues and procedural questions
- Supported regulatory submissions, startup activities, and contract negotiations
- Transitioned and onboarded multiple team members globally without disrupting research operations
- Successfully transitioned active patients to Post-Trial Access programs during company restructuring
- Contributed to the release of long-term data demonstrating improved outcomes for SMA patients treated with Zolgensma
- Consistently received SPARK Global Recognition Awards for project management excellence
Assistant Manager, Education and Quality Improvement Program (E-QIP) & Clinical Research Trials Office (CRTO)
Atlantic Health System
08.2018 - 04.2021
- Established the E-QIP and CRTO programs to support efficient research operations, training, and quality improvement
- Developed and supervised frameworks for sponsored and investigator-initiated trials, including staffing, training, and study operations
- Implemented patient recruitment and retention programs, reducing First Patient First Visit (FPFV) timelines by 50%
- Designed COVID-19 research operation processes to mitigate pandemic-related challenges
- Trained over 100 research coordinators and investigators in Good Clinical Practice and compliance
- Expanded AHS’ research portfolio, establishing six new research sites across therapeutic areas
- Reduced Site Initiation Visit (SIV) timelines by half through process streamlining
- Successfully rolled out EPIC electronic medical records for research, receiving recognition for exceptional performance
Coordinator, Quality Improvement Program (QIP)
Atlantic Health System
05.2015 - 08.2018
- Developed and implemented the Quality Improvement Program, which grew into E-QIP and CRTO
- Presented AHS’ Quality Improvement Program at Harvard’s QA/QI Boot Camp
Research Nurse Coordinator, Institute of Neurology & Neurosurgery
Saint Barnabas Medical Center
12.2008 - 05.2015
- Established the INN Research Department, increasing trial volume from 1 to 15 within a year
- Coordinated pivotal device trials and industry-sponsored studies, contributing to FDA approvals for Cannabidiol (Epidiolex) and the Responsive Neurostimulator (RNS)
- Co-authored research manuscripts on epilepsy and autism
Education
Master of Science - Nursing (Clinical Research Management)
Drexel University
Philadelphia, PAPost-Bachelor Certificate - Clinical Research Management
Drexel University
Philadelphia, PABachelor of Science - Nursing
Silliman University
Skills
- Clinical Trial Operations
- Leadership and Decision Making
- People Management and Mentorship
- Clinical Research Investigator and Staff Training
- Risk and Adverse Event Management
- FDA Regulations and GCP Guidelines
- Good Documentation Practices
- Protocol Development and Regulatory Compliance
- Program Design and Project Management
- Budget Management
- Cross-functional teamwork
- Team leadership
Accomplishments
- Supervised the transition and onboarding of multiple study team members at the local and global level without interruption in research operations.
- Spearheaded all protocol and ICF writing and subsequent amendments for assigned studies. Drove protocol amendment approvals on schedule amidst frequent staff turnover and minimized delays in protocol implementation.
- Oversaw the successful transition of all active patients in the CPDR001F2301 Study to Post Trial Access programs on schedule despite companywide restructuring and frequent staff changes.
- Supported the preparation and release of long-term data results of LT001 and LT002 which showed improved and sustained health and wellbeing of the Spinal Muscular Atrophy (SMA) patients who received Zolgensma.
- Integrated all assigned studies to Novartis Pharmaceuticals to align with company restructuring.
- Spearheaded resolution of TMF audit queries prior to transition.
- Consistent recipient of SPARK, a Novartis Global Recognition Award for successful project management and implementation.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
Certification
- Registered Nurse, NJ
- Certified Clinical Research Professional, CCRP
Affiliations
- Society of Clinical Research Professionals (SOCRA)
- Sigma Theta Tau International Honor Society of Nursing, Nu Eta Chapter
Awards
- SPARK Global Recognition Program Award (Novartis)
- PRIDE in Action Award (Atlantic Health System)
- Exceptional Performance in EPIC Research Rollout (Atlantic Health System)
Languages
English
Full Professional
Tagalog
Full Professional
Interests
- Travelling Exploring famous landmarks, historical sites, and cultural attractions in a new destination
- Hiking
- Swimming
- Learning a new language
Timeline
Senior Global Trial Manager
Novartis Pharmaceuticals Corporation
05.2021 - 06.2024
Assistant Manager, Education and Quality Improvement Program (E-QIP) & Clinical Research Trials Office (CRTO)
Atlantic Health System
08.2018 - 04.2021
Coordinator, Quality Improvement Program (QIP)
Atlantic Health System
05.2015 - 08.2018
Research Nurse Coordinator, Institute of Neurology & Neurosurgery
Saint Barnabas Medical Center
12.2008 - 05.2015
Post-Bachelor Certificate - Clinical Research Management
Drexel University
Bachelor of Science - Nursing
Silliman University
- Registered Nurse, NJ
- Certified Clinical Research Professional, CCRP
Master of Science - Nursing (Clinical Research Management)
Drexel University
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