小型会议 2011年12月8日

09.00-12.00 Workshop A: Working Together to Develop a Healthy Talent Pipeline in China on Clinical Data Management

Attend the workshop to learn and share your insights in:

• How to build a fast learning organisation of clinical trail data management in China
• The impact of the cultural capabilities for a data manager working in global study team
• The importance of collaborating with other functions to grow data management capacity in emerging market
• The feasibility of cross company collaborations to enlarge the volume and improve the quality of talents on clinical data management in China

Your Workshop Leader:

Jessie Chen
Head of Global Clinical Data Services
Pfizer (China) Research & Development Center

Jessie Chen is the head of Global Clinical Data Services (GCDS) Department in Pfizer China R&D Center (CRDC) since 2008. The department provides data processing, database build and data management services to Pfizer global phase 1 to phase 4 clinical trials and post marketing noninterventional studies on close to 70 products in 11 therapeutic areas since it established in 2006.

Before that, Jessie had worked on SOPs, training, and process implementation for 2 years supporting multiple functions of Pfizer Development Operations in CRDC as well as the medical/ clinical operations organisations in 12 countries of Asia/Australia region.

Prior to joining CRDC, Jessie had worked in Pfizer China Medical department for 8 years where she obtained extensive experiences on clinical operations.

小型会议 2011年12月8日

14.00-17.00

Streamlining Execution of Clinical Trials through Optimising Efficiency of Clinical Data Management

• Demonstrating how standards can provide consistency and lessen the burden of formatting and configuration for technical staff
• Simplifying extraction and pooling of data by maintaining designed standards throughout each stage of the trial
• Moving towards full automation through integration in an effort to minimise the challenge of data transfer and lower the need for maintenance
• Analysing to what extent full automation could affect personnel within technical and programming fields
• Using outsourcing partners to share tasks and allow in-house resource to be spent elsewhere
• Determining whether true outsourcing partnerships could act as a buffer to job losses within data management through CRO adoption of sponsor sites
• Investigating offshoring as a way to lower costs and whether this is a long-term solution
• Addressing industry anxiety associated with company restructure and the role of the data manager

Your Workshop Leader:

Julia Zhang
Associate Director, Standard Programme Manager
Genzyme Pharmaceuticals

Dr. Zhang has worked in Pharmaceutical and Biotechnology Industries for 14+ years. She is an active member of HL7 and CDISC standard organizations. Her expertise is in the following areas:

• regulatory submissions both in paper and electronic
• development/implement industry standards (HL7, CDISC) for submission, statistical analysis reporting and clinical trial data collection
• statistical analysis on clinical trial
• data management, such as clinical data collection (EDC), reviewing, cleaning, and exchange, etc.
• Clinical trial database design
• Program/project management. Her broad clinical experiences across different therapeutic areas include Infectious Diseases, Respiratory, Oncology, Rare Inherited Disorders, etc.