AYAKO IIJIMA
4-14-40 Kitaterao Tsurumi-ku, Yokohama-shi, Kanagawa-ken,14
Summary
Resourceful Clinical Project Manager with 3+ years for 4 projects in Contract Research Organization. Experiences in full-scope studies including monitoring, DM, STAT, MW, IDMC, medical monitoring, and PV. Experiences in developing SOPs and operations related to clinical QMS and RBM. Skilled at identifying "critical to quality factors" and managing trial-specific risks by training team members and developing operational mitigation plans. Experiences in outsourcing monitoring, DM, and medical monitoring to multinational CROs and managing these third-party organizations as a global PM.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Trial Project Manager
Intellim Corporation
05.2021 - Current
Assistant Clinical Project Manager
Intellim Corporation
11.2018 - 08.2020
- Managed and monitored clinical trial sites as per protocol, study-specific data safety monitoring plan, ICH/GCP guidelines, sponsor SOPs and processes.
- Managed project activities compromising study start-up activities, site initiation, monitoring, close-out, and database locks.
- Assist in protocol, Informed Consent, and CRF design and review
- Verify subject safety and site adherence to FDA Regulations, sponsor requirements, and ICH/GCP Guidelines
- Mentored office employees on proper procedures, keeping operations consistent and efficient for maximum performance.
Clinical Research Coordinator
Centura Health
05.2016 - 05.2018
- Acted as primary clinical sponsor contact on behalf of PI-Sponsors for investigative sites, outside vendors, and funding sponsors
- Established and served as lead central contact between participating clinical sites and sponsor-investigators for multiple clinical trials.
- Administered and coordinated logical aspects of clinical trials per CTA, SOPs, and protocols
- Created, evaluated, managed, and preserved TMFs, SSFs, and essential documents in compliance with FDA, ICH/GCP regulations, local laws, sponsor and IRB requirements
Education
Bachelor of Arts - Psychology
Ithaca College
Ithaca, NY05.2015
Skills
- Comprehensive management of QTLs, including setting trial-specific QTLs, developing specification, QTL review and implementing action plans in study period
- Identify critical data, supervise risk assessment activities involving team members from all roles in scope of contract
- Protocol review based on risk assessment (also experience in creation of entire protocol in a clinical trial)
- Consideration of EDC data collection items based on discussions with medical experts and specification review for entire EDC development
- Creating and managing the entire project schedule from the start of protocol creation to CTD approval
- Multinational vendor selection and oversight such as schedule/quality/budget management etc (Monitoring; Vietnam and Thailand, DM; China, Medical monitoring; India)
- Introducing the protocol contents and responsibilities of IDMC members, and facilitating IDMC meetings (Philippines, Japan)
- Discussion with DM/STAT members regarding interim analysis policy and specification review for DBL
- Oversight monitoring and preparation of on-site compliance inspection by PMDA at clinical sites in Vietnam
- On-site vendor assessment (SOP, document storage, training system, BCP, QMS, IT security and privacy policy etc;) visit at local CRO (Vietnam) in study termination
- QMS consultation to clinical sites and Pharmaceutical companies
Certification
- ICH GCP Certification
- CITI HIPAA Research training
- Human Subjects Protection Training
Accomplishments
- Co-Authored on seven individual publications within leading journals such as Leukemia, Nature Cell Biology, Cancer, and Blood
Languages
German
Timeline
Clinical Trial Project Manager
Intellim Corporation
05.2021 - Current
Assistant Clinical Project Manager
Intellim Corporation
11.2018 - 08.2020
Clinical Research Coordinator
Centura Health
05.2016 - 05.2018
Bachelor of Arts - Psychology
Ithaca College
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