Wendy Lim
Summary
Dynamic Clinical Trial Consultant with extensive experience and adept at developing clinical strategies and managing multidisciplinary teams. Proven problem-solving and strong project management skills ensure compliance with GCP and regulations, driving successful clinical research outcomes. Recognized for attention to detail and effective communication, fostering collaboration across diverse stakeholders.
Overview
26
26
years of professional experience
Work History
Clinical Trial Consultant
MedRationale Pte. Ltd.
09.2023 - Current
- Develop clinical strategy for products in development in coordination with client.
- Provide Clinical Project Management services to clients.
- Provide Clinical Site Management services to clients.
- Provide necessary clinical trial training to clients as required.
Clinical Trial Lead
EndoMaster Pte Ltd
04.2019 - 12.2024
- Develop clinical strategy for products in development in coordination with regulatory and marketing strategies.
- Evaluate, select and manage CROs and any relevant vendors · Develop clinical strategy for products in development in coordination with regulatory and marketing strategies.
- Evaluate, select and manage CROs and any relevant vendors that are required to support clinical research programs.
- Manage clinical research projects, including leading multidisciplinary team and/or management of CRO team(s) in the execution of clinical projects to deliver results.
- Develop and oversee the development of project plans, program budget and study tracking tools.
- Ensure clinical research programs are conducted in accordance with company SOPs, GCP, and specific country regulations.
- Participate in and lead process improvement activities within the department and cross functionally, including Quality Management System SOP development.
- Develop and review clinical protocols, informed consent forms and case report forms and case report forms, in conjunction with relevant subject matter experts, department and vendors.
Project Manager
Medtronic Plc.
03.2014 - 10.2018
- Manage clinical research projects, including leading multidisciplinary team and/or management of CRO team(s) in the execution of clinical projects to deliver results.
- Develop and oversee the development of project plans, program budget and study tracking tools
- Ensure clinical research programs are conducted in accordance with company SOPs, GCP, and specific country regulations.
- Provide direction, subject matter expertise and support to CRAs, and CROs as needed.
- Develop and review clinical protocols, informed consent forms and case report forms and case report forms, in conjunction with relevant subject matter experts, department and vendors.
- Evaluate and select CROs and any relevant vendors that are required to support clinical research programs.
- Ensure appropriate recruitment / selection investigational sites to participate in clinical studies.
- Oversee and participate in in-country and international clinical program activities.
- Initiate annual review, revision, new development, training and implementation of SOPs.
- Develop training materials for clinical affairs personnel.
- Initiate and conduct continuous internal process improvement and new process implementation.
- Recruits staff members conducts performance appraisals and fulfills other managerial responsibilities.
Manager, Regulatory, Compliance & Monitoring
Ever Progressing System Pte Ltd (EPS Singapore)
01.2006 - 07.2013
- Development of regulatory and compliance SOPs
- Oversee all regulatory and compliance aspects of multiple clinical research programs.
- Conducting periodical audits (systems and site)
- Develop regulatory training materials.
- Provide regulatory consultation for clinical research programs.
- · Oversee operational aspects of multiple clinical research programs, to support sponsor objectives.
- Manage clinical research projects, including leading multidisciplinary team and/or management of monitoring team(s) in the execution of clinical projects.
- Develop and oversee the development of project plans, program budget and study tracking tools.
- Ensure clinical research programs are conducted in accordance with sponsor company SOPs, GCP, and specific country regulations.
- Provide direction and monitoring support to CRAs.
- Initiate annual review, revision, new development, training and implementation of SOPs.
- Develop monitoring training materials.
- Conduct periodic training on monitoring skills.
Clinical Project Coordinator (Contract)
Clinical Trials & Epidemiology Research Unit
05.2005 - 01.2006
Clinical Research Associate
AstraZeneca Singapore Pte Ltd
09.1999 - 02.2005
Education
State Registered Nurse - Nursing
School of Nursing
Singapore04-1992
Skills
- Problem-solving
- Attention to detail
- Verbal and written communication
- Multitasking Abilities
- Issue resolution
- Time management
- Project management
Additional Information
Monitoring / Project Management / Project Management Oversight / Clinical Trial Consultant
Oncology
- I & II – 8
- RA and IRB submission (Singapore)
- Feasibility studies
Neurology
- III – 4
- RA and IRB submission (Singapore)
- Feasibility studies
Endocrine
- II – 2
- RA and IRB submission (Hong Kong)
Cardiology
- IIIB – 1
- RA and IRB submission (Singapore)
Respiratory
- IV – 1
- RA and IRB submission (Singapore)
Rheumatoid Arthritis
- II – 1
- RA and IRB submission (Singapore)
Gastrointestinal
- IV – 1
- RA and IRB submission (Singapore)
Hepatology
- III – 1
- RA and IRB submission (Singapore)
Ophthalmology
- IV – 1
- RA and IRB submission (Singapore)
Medical Device
- Post-Market – 4
- Pre-Market – 2
- Remote initiation of Medical Device Clinical trial during COVID-19. Clinical trial was conducted in Hong Kong, EndoMaster Team was in Singapore.
Timeline
Clinical Trial Consultant
MedRationale Pte. Ltd.
09.2023 - Current
Clinical Trial Lead
EndoMaster Pte Ltd
04.2019 - 12.2024
Project Manager
Medtronic Plc.
03.2014 - 10.2018
Manager, Regulatory, Compliance & Monitoring
Ever Progressing System Pte Ltd (EPS Singapore)
01.2006 - 07.2013
Clinical Project Coordinator (Contract)
Clinical Trials & Epidemiology Research Unit
05.2005 - 01.2006
Clinical Research Associate
AstraZeneca Singapore Pte Ltd
09.1999 - 02.2005
State Registered Nurse - Nursing
School of Nursing
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