Barbie Wu
Clinical Trial Manager
Summary
Coming from a clinical nursing background as a license nurse familiar with medical setting, hospital environment and regulations. Over ten years of experience in clinical studies, including four years as a Study Coordinator, five years as a Clinical Research Associate (CRA), and three and half years as Clinical Trial Manager (CTM). Experienced in managing clinical studies from Phase I to IV in a wide range of therapeutic areas including Immunology, oncology, hematology, infectiology, neurology, dermatology in both pharmaceutical and clinical research organization settings in APAC countries such as Australia, New Zealand, Taiwan, South Korea, India, Thailand, Singapore, Malaysia, Philippine, and Hong Kong. Due to relocation to Launceston Tasmania with my husband, I'd like to seek remote Clinical Trial Manager or Project Manager working opportunity in Australia.
Overview
14
14
years of professional experience
4
4
years of post-secondary education
Work History
APAC Clinical Trial Manager
ICON, Formerly PRA Health Sciences, Taipei, Taiwan
11.2021 - Current
- Independently manages delivery of complex clinical studies. May be assigned as the Global Clinical Team Manager or project lead.
- Collaborates with the project team in creation and execution of sponsor and cross-functional team communications, identifying issues and risks and potential solutions.
- Provides training and guidance to less-experienced Clinical
Team Managers (CTMs) as well as clinical study team members. - Contributes to creation/ updates of training materials.
- Support Project manager (PM) for project resource and finance management.
Senior Clinical Research Associate
ICON, Formerly PRA Health Sciences, Taipei, Taiwan
04.2020 - 10.2021
- Independently performs a wide variety of onsite and offsite monitoring visit types. Routinely assigned studies that require complex therapeutic knowledge.
- Serves as preceptor, providing training and coaching feedback to less experienced clinical team members. May provide input to training and development programs.
- Independently anticipates study risks and proactively establishes methods to address them.
- Independently leads or assists with ad hoc, short-term assignments in support of study or departmental initiatives.
- Leverages expertise to contribute to process and system improvements.
- Assigned clinical tasks where advanced negotiating skills
are required, as needed.
Clinical Research Associate
ICON, Formerly PRA Health Sciences, Taipei, Taiwan
06.2017 - 03.2020
- Independently performs a variety of onsite and offsite monitoring visit types.
- Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates
as appropriate. - Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
- May serve as preceptor, providing training to less experienced clinical team members.
Clinical Research Associate
QuintilesIMS, Taipei, Taiwan
05.2015 - 06.2017
- Independently performs a limited range of onsite and offsite monitoring visit types.
- Gathers and reviews information for assigned sites and identifies inconsistencies. With guidance from project and functional management, assesses risk and escalates as appropriate.
Research Study Coordinator
National Taiwan University Hospital, Taipei,Taiwan
02.2011 - 04.2015
- Assisted and participated audit and inspection.
- Global trial, Investigator Initiated Trial, and subject management.
- Participated in protocol design in localized studies.
- Participated site initiation, interim monitoring, and close-out activities.
- Study Budget reviewing.
- Ensured study conduct in compliance with GCP.
- Ethics Committees submissions.
- Data collection, eCRF entering and query resolution.
- Recruitment management.
Registered Nurse
Taipei Veterans General Hospital, Taipei, Taiwan
08.2008 - 11.2009
- Managed and directed nursing care activities during the patients hospital stay.
- Documented the effectiveness of nursing care and modified plan of care as patient progresses toward expected outcomes.
- Involved the family when providing care and in decision-making as appropriate.
- Collaborated with appropriate health team members for coordination of daily plan of care for assigned patients.
- Provided and documented nursing interventions based on assessed patient needs, and plan of care.
Education
Bachelor of Science - Nursing
National Taiwan University
Taipei, Taiwan 09.2004 - 06.2008
Skills
Excellent knowledge of the drug development process
Timeline
APAC Clinical Trial Manager
ICON, Formerly PRA Health Sciences, Taipei, Taiwan
11.2021 - Current
Senior Clinical Research Associate
ICON, Formerly PRA Health Sciences, Taipei, Taiwan
04.2020 - 10.2021
Clinical Research Associate
ICON, Formerly PRA Health Sciences, Taipei, Taiwan
06.2017 - 03.2020
Clinical Research Associate
QuintilesIMS, Taipei, Taiwan
05.2015 - 06.2017
Research Study Coordinator
National Taiwan University Hospital, Taipei,Taiwan
02.2011 - 04.2015
Registered Nurse
Taipei Veterans General Hospital, Taipei, Taiwan
08.2008 - 11.2009
Bachelor of Science - Nursing
National Taiwan University
09.2004 - 06.2008
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