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Summary

A team-oriented clinical research professional with passion and strong clinical footprint in APAC who has demonstrated innovation, and general project management competencies with a successful track record in clinical trial management. More than 13 years of progressive experience in the Clinical Research, across both Pharmaceutical and CRO industry. Strong background on process improvements, “Compliance, process & training”, and team building. Worked as Clinical Research Associate (CRA), Lead/Start-up Specialists, Project Manager, Senior Clinical Operation Manager, as well as Quality Management System and training management prior to current role in PAREXEL. Experienced in providing strategic leadership in areas of quality, audits and inspections have earned the role of Country Quality Responsible in previous assignment. Experienced in areas of oncology, hematology, psychiatry, stroke, trauma, rheumatoid arthritis, osteoporosis, diabetes, transplant, asthma, gastroenterology and cardiovascular.

Strenghts

  • Bachelor's degree in Medical Sciences with strong 13 plus years of clinical trials and clinical project management, including 6 years of experience in a leadership capacity
  • Project Management experience in global study involving APAC, EU & US sites
  • Extensive experience in start-up, site monitoring, feasibility, start-up and close-out activities (since 2012)
  • GCP/GVP Quality Management, CAPA Management (since 2010) & Compliance, Process & Training (since 2009)
  • Country resource, budget & vendor management
  • Line Manager for CRA and Start-up Specialist (since 2009)
  • Strong knowledge in ICH-GCP and regulation, in both Pharmaceutical and CRO environment
  • Experience working independently in both home and office based, including setting up home office in Malaysia
  • Analytical & objective, focus on problem solving & issue resolution. Ability to detect issues and provide solutions to ensure project productivity
  • Great interpersonal skills and a strong team player. Ability to work with Regional/Global, as well as local team.
  • Able to multitask, and prioritize important/urgent task accordingly.
  • Advanced knowledge of clinical research financial parameters and project financial tracking and accounting methods, Excellent in utilizing metrics and Key Regional datas (eg. Monthly Country/Project scorecards) to access project and Country status and oversight. Thus, demonstrates ability to track and follow-up on agreed timelines. Appropriately escalates issues when necessary.

Achievements

  • Sucessfully led the transition of 3 clinical trial monitors from Roche to preferred CRO from 1-Aug-2014. 11 in-sourced studies were also transferred from Roche to preferred CRO as part of Roche’s globally decision to outsource all site monitoring activities.
  • Recognized by Regional Head of Clinical Operations Asia-Pacific for outstanding performance and lasting contributions to “Reduction of Study Costs” for Malaysia and Singapore, and for taking smart risks.
  • As an affiliate quality responsible, Quality Management handbook, Quality Plan, and Quality Management Tool was written from draft and finalized/signed off by General Manager in Aug-2014. Management Committee review meeting was successfully conducted in Aug-2014.
  • Recognized with Silver Excellence Award for excellence in appreciation of PASS Study BH21260 – event based study requiring global site participation. Malaysia has recruited 17 patients within 1 month.
  • Developed Clinical Operation team in Roche Malaysia from 1 to 4 headcounts. The team continues to grow at a rate of minimum 1 new headcount per year. Since joining Roche Malaysia, number of in-sourced study grows from 1 to more than 10 active studies within 3 years. The number of new studies continues to grow at 1 – 2 new studies per year. 
  • Successfully developed more than 10 local working procedures since joining Roche Malaysia. Developed and supported global SOP development. Participated as facilitator in Global monitoring cost, supporting the Global/Regional Process and Training team.
  • Overseen more than 2 site audits, and 2 affiliate audits within 2 years. Significant issues noted were successfully closed and mitigated within the agreed timelines.
  • Compliance Manager (GCP & GVP) for Roche initiated Global Quality Management project. The aim of the project is to improve companywide “compliance” activities/process to match industry standards by year 2016.
  • Successfully setup home based office for 2 CROs in Malaysia and in both cases, is the pioneer of the CROs in Malaysia.

Work History

Dec 1, 2014Current

Project Leader

PAREXEL International

Simplified Job Descriptions:

  • Owns the client relationship and responsible for client communication ensuring high client satisfaction. Pro-active approach to providing solution set for clients.
  • Lead all aspects of global project management from financial management, ensuring project profitability, internal resource throughout the study
Sep 1, 2009Nov 30, 2014

Country Head / Clinical Research Manager

Pharma Development Operations, Roche Malaysia

Simplified Job Descriptions:

  • Affiliate Head of Clinical Operation (Country budget & resource management)
  • Vendor Management
  • Country Start-up Management
  • Compliance, Process & Training
  • Quality Management System: GCP/GVP Quality & CAPA Management
  • Project Management for Regional studies
  • Line Management
  • Job Descriptions: Refer to Attachment 1.

Duration: 5 years

Reason for Leaving: Clinical operation team was outsourced to a CRO (global decision).

Sep 1, 2007Aug 31, 2009

Lead/Start-Up Clinical Research Associate

PPD Development Pte Ltd, Singapore (Singapore Based)

Simplified Job Descriptions:

  • Start-up and regulatory specialist responsible in site feasibility and site start-up activities in Malaysia and Singapore.
  • Single point of contact for Regulatory/ICH-GCP related to Malaysia 
  • Site management/monitoring activities including site-selection, start-up, monitoring and close-out (APAC)
  • Project management (associate level) eg. vendor management, budget, kick-off meeting, co-monitoring, monitoring report review, etc. (APAC)

Duration: 2 years

Reason for Leaving: Leaving for a more senior role as the Head of Clinical Operations in Malaysia.

Jun 1, 2006Aug 31, 2007

Senior Clinical Research Associate

ICON Clinical Research Pte Ltd, Singapore (Home Based)

Simplified Job Descriptions:

  • Single point of contact for monitoring activities in Malaysia
  • First ICON site monitor to be based in Malaysia (home based), responsible to setup home-office and starting point for ICON.
  • Site management/monitoring activities including site-selection, start-up, monitoring and close-out

Duration: 1 year

Reason for Leaving: Exposure to CRO settings in Singapore and monitoring experience in Asia Pacific region, Start-up CRA role, Project Management opportunities, & enhancement of personal developments.

Jun 1, 2005May 31, 2006

Clinical Research Associate (International Clinical Research Operation)

Novartis Corporation (Malaysia) Sdn Bhd

Simplified Job Descriptions:

  • Study Management of outsourced studies
  • Site monitoring team lead in Malaysia
  • Site management/monitoring activities including site-selection, start-up, monitoring and close-out

Duration: 1 year

Reason for Leaving: Exposure to settings in Contract Research Organization (CRO) & as a home based monitor.

Sep 5, 2002May 31, 2005

Clinical Research Associate (Contract)

Merck Sharp & Dohme (I.A.) Corp., Malaysia Branch

Simplified Job Descriptions:

  • Entry level site monitor
  • Site management/monitoring activities including start-up, monitoring and close-out

Duration: 3 years

Reason for leaving: Explore a permanent role. Personal development opportunities.

Therapeutic Experience

Indication

Phase

# Patients

# Sites

Countries

Services Involved

Non Small Cell Lung Cancer

II

150

65

Republic of Korea, Taiwan, Malaysia, Philippines, Japan, Spain, Italy, US

Full service, Project Leadership

Major Depressive Disorder

III

880

60

Australia, Japan, Republic of Korea, Malaysia, Taiwan

Non-client facing Project Leadership

Metastatic Breast Cancer

III

24

5

Malaysia

Feasibility, Start-up & Vendor Oversight

Non Small Cell Lung Cancer

III

18

2

Malaysia

Feasibility, Start-up/CRA Line Manager & Vendor Oversight

Chronic Kidney Disease, Dialysis

III

17

3

Malaysia

Feasibility, Start-up/CRA, Start-up/CRA Line Manager & Vendor Oversight

Rheumatoid Arthritis

III

10

3

Malaysia

Feasibility & CRA

Type II Diabetes

III

120

8

Malaysia

Feasibility, Start-up/CRA Line Manager

Metastatic Gastric Cancer

III

20

4

Malaysia

Feasibility, Start-up/CRA Line Manager & Vendor Oversight

Non-Hodgkin Lymphoma

III

28

4

Malaysia, Philippines, Singapore, South Korea

Project Management, Vendor Management

Non-Hodgkin Lymphoma

III/IV

8

3

Malaysia

Project Management, Vendor Management

Trauma

III

10

4

Singapore, Malaysia

Feasibility & Start-up/CRA

 

Early Breast Cancer

III

60

4

Malaysia, Singapore, Indonesia, South Korea

Feasibility, Start-up/CRA Line Manager & Project Management

 

Cardiovascular

III

60

6

Singapore, Malaysia

Feasibility & Start-up/CRA

 

Thalassemia

III

60

2

Malaysia

Feasibility & Start-up/CRA

Kidney Transplant

III

6

1

Malaysia

Feasibility & Start-up/CRA

Hypertension

III

160

6

Malaysia

Feasibility & Start-up/CRA

Osteoporosis

III

50

4

Malaysia

Feasibility & Start-up/CRA

Pediatric Asthma

III

2

40

Malaysia

Feasibility & Start-up/CRA

Education

Sep 5, 2002Sep 5, 2002

Bachelor of Biomedical Science

University of Malaya, Malaysia

CGPA: 3.55/4.00

19981998

Malaysia Higher School Certificate (STPM)

SM Taman SEA, Petaling Jaya

2A’s, 3B’s (84 Points)

19961996

Malaysian Certificate of Education (SPM)

SM Seaport, Petaling Jaya

9A1’s

(Aggregate 6 - Grade 1)

19961996

Sijil Perdagangan Malaysia: Simpankira

SM Seaport, Petaling Jaya

Grade 1

19961996

General Certificate of Education (English 1119)

University of Cambridge Local Examination Syndicate

Grade C

19941994

Penilaian Menengah Rendah (PMR)

SM Seaport, Petaling Jaya

7A’s (Grade 1)

Extracurricular Activities

1999 - 2001

President of Biomedical Science Society, University of Malaya

·         Actively involved in all activities organized by the society

1997 - 1998

Project Director of Science & Maths Society

·         Participated in Australian National Chemistry Quiz

·         Committee & Participant for Carnival Science Project (Petaling District)

1995 - 1996

Sales Assistant Director of School Co-Operation

·         Led a Team of 4 Members to Participate in Sales & Marketing Projects

Awards

Sep 30 – Oct 1, 2010

Effective Negotiation & Influencing Skills

· Organized by Cleverbridge & Sponsored by Roche (Malaysia) Sdn Bhd

Sep 13 – Sep 15, 2010

Leadership & Management Skills for Managers

· Organized by CCM Events Asia

· Sponsored by Roche (Malaysia) Sdn Bhd

Mar 8 – Mar 19, 2010

Global Monitoring Course, Australia

· Organized & Sponsored by Roche (Dee Why) Pty Ltd

Nov 28 – Dec 7, 2007

Clinical Foundation Program, Singapore

· Organized & Sponsored by PPD Development Pte Ltd

Sep 1 – Sep 5, 2005

CTMS/ClinAdmin Training for Malaysian Planners at Novartis Headquarters (Basel, Switzerland)

Jan 1, 2005

Contributed as a facilitator in the Good Clinical Practise Workshop

Organized by Clinical Investigation Centre, University Malaya Medical Centre

Dec 20 – Dec 21, 2004

 

Merck Sharp & Dohme CRA Refresher Training

· Organized by Merck Sharp & Dohme (I.A.) Corp., Malaysia branch

· Training Conducted by ICON Clinical Research Pte Ltd

Feb 1 – Feb 5, 2003

Clinical Trial Management System (CTMS) Training at MSD Europe (Brussels, Belgium)

Oct 1, 2002

Good Clinical Practise (GCP) Workshop, Organized by Clinical Trial Units, School of Medical Sciences, University of Science Malaysia

2002

Final year thesis of Biomedical Science at Molecular Pathology Lab, University Malaya Medical Centre

· Title: Development of a Liquid Hybridization Assay for the Detection and Quantitation of Hepatitis B Virus DNA in Clinical Specimens

· (Obtained an A for the thesis)

1997

School Representative in Australian National Chemistry Quiz 1997 in the Senior Division

· Obtained a Distinction Awarded by Royal Australian Chemical Institute

1996

Grade 1 in Bookkeeping of Sijil Perdagangan Malaysia

1996

Best students for Physics and Bahasa Malaysia for SPM 1996

1996

Receiver of award (Hadiah Bestari Awang Had 1996)

· Best achievement of Bahasa Malaysia, English, Science and Mathematics Organized by Informatics

1995

School Representative in Olympiad Mathematics Competition 1995

· Held in Universiti of Malaya, Malaysia

1994

Lower Secondary School Science Quiz 1994 (Petaling District)

· First Runner Up for Petaling District

Languages

Language

:

Spoken – Malay Language, English, Mandarin & Cantonese

 

Written – Malay Language & English

Computer Literacy

Word Processor

:

Microsoft Word

Spread Sheet

:

Microsoft Excel

Slide Presentation

:

Microsoft Powerpoint

Clinical Trial systems

:

Clinical Trial Management System (CTMS)

Electronic Data Capture (EDC)

Electronic CRF (eCRF)/RAVE/InForm/WinFx Clinical Trial Management Tool, WAES (Worldwide Adverse Event Reporting), Interactive Voice/Web Reporting System (IxRS), shareweb, sharepoint, touchpoint

Expectation

Expected Salary

:

Open for negotiation, 13-month salary, performance bonus

Mobility

:

Yes

Notice Period

:

8 Weeks

References

Available upon request.