Winnie P. Leung
Foster City,CA
Summary
Accomplished Clinical Data Management Leader with 20+ years of clinical trial experience across top biotechnology and pharmaceutical organizations. Expert in day-to-day CDM execution, project-level data strategy, vendor/CRO oversight, EDC database build/lock, and cross-functional team leadership. Proven ability to align Biometrics DM activities with Early Clinical Development (ECD) milestones to accelerate Study Start-up, Snapshot, and Database Lock timelines. Demonstrates technical expertise in Medidata Rave EDC, CDISC/SDTM standards, medical coding, CRO governance, and automated clinical systems (IxRS, eCOA, DDC, AI query tools).
Overview
1
1
Certification
24
24
years of professional experience
Work History
Principal Data Operations Leader
Genentech, Inc. A Member of the Roche Group
South San Francisco, USA
11.2023 - Current
- Spearheaded the strategic technical vision, architecture, and end-to-end lifecycle of high-impact clinical systems across ECD CI&A, driving cross-functional innovation, scaling adoption, and mentoring teams in best-practice technology implementation
- Direct line managed a team of Senior Clinical Systems Leaders accountable for managing end-to-end clinical systems ( IRT/IxRS and eCOA) delivery across early-phase portfolios in collaboration with Clinical Operations
- Direct oversight of outsourced
service providers/vendors, enforcing Service Level Agreements, establishing negotiation best practices, and conducting invoice audits that recovered thousands in overcharges - Developed a Study Build Tracker and Dashboard to monitor resources & vendors allocation, track study status and milestones, quantify performance metrics, and enable proactive risk mitigation
- Direct oversight of outsourced service providers/vendors, enforcing Service Level Agreements, establishing negotiation best practices, and conducting invoice audits that recovered thousands in overcharges
- Established consolidated communication channel and centralized issue tracking framework to standardize DM delivery expectations, ensure accountability, and resolve site/study team pain points
- Provided guidance to TA leader and study team on effective data management strategies.
- Collaborates with other line functions to align and simplify processes in data review/reconciliation
- Uses strong technical expertise and skills to find opportunities for automation, efficiency and simplification with the mindset of working smarter. Proposed an AI-driven root cause analysis tool for clinical queries. represented gRED in the EHR2EDC workstream, and AI/automation tools to streamline protocol ingestion into
system specifications,
Principal Data Sciences Product Leader
Genentech, Inc. A Member of the Roche Group
South San Francisco, USA
10.2022 - 10.2023
- Develop and manage custom study-level data visualizations for Clinical and Safety Scientists to conduct Medical Data Review (MDR) and safety signal detection
- Contributed to diverse data science projects/products and PD portfolio, enhancing overall project outcomes
- Established expertise in key areas within PDD, influencing team strategies and decision-making
- Seek opportunities for innovation & automation focusing on tools, systems and processes: Working smarter, capitalizing on efficiencies, looking for opportunities to improve or harmonize tools and processes
- Embedded best practices and effective ways of working within sub-function, improving team collaboration and efficiency
- Built partnerships with stakeholders by providing visual analytics training and support for Clinical Science and Safety Science groups in early and late stage development.
- Collaborate effectively with a diverse group of stakeholders
- Supportive and positive influence on peers, e.g. mentoring and upskilling
Senior Data Sciences Product Leader
Genentech, Inc. A Member of the Roche Group
South San Francisco, USA
06.2021 - 09.2022
- Led the development and implementation of Data Sciences products.
- Delivered technical, business, and therapeutic area expertise to create PDD products that met global standards.
- Contributed technical expertise to strategic planning and execution, collaborating and influencing to position Data Sciences at the forefront of the industry.
- Regularly review opportunities to simplify, innovate and collaborate with experts within and outside of PDD to accelerate and deliver patient benefits faster
- Demonstrated system awareness while building partnerships and fostering collaboration with stakeholders across Roche to support programs, processes, systems, and compliance.
- Managed implementation of medical data review processes and tool applications (e.g. Spotfire) for scientists through training, best practice development, and dedicated support.
- Aligned the practice of medical data review consistently across all Roche/Genentech sites and therapeutic areas.
- Continuously look for opportunities to broaden knowledge and skill set. Role model knowledge sharing within PDD and beyond. Act as a coach or mentor to help colleagues develop
Senior Data Manager
Genentech, Inc. A Member of the Roche Group
South San Francisco, USA
06.2019 - 05.2021
- PROJECT MANAGEMENT: Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies and project responsibilities, including the implementation and adoption of new technologies
- VENDOR MANAGEMENT: Partner with relevant functions for external data vendor selection and management. Oversee development of data transfer agreements with vendors ensuring use of standards, fit-for-purpose data models and transfer intervals
- DATA COLLECTION AND ACQUISITION: Act as experts for data collection, advising teams and stakeholders on best practices and proposing innovative solutions. Ensure a high quality of data and compliance with applicable pharma industry regulations and standards
- DATA QUALITY REVIEW: Use data surveillance tools and strategies to provide aggregate level reviews designed to identify patterns or anomalies in our data to ensure high quality results
- SUPPORT ANALYSES: Partner with stakeholders to understand their data insight needs and offer Data Management solutions. Demonstrate a strong understanding of the data flow from collection through to analysis and filing
- TECHNICAL CONSULTANT: Offer guidance and advice to peers within the function, to key stakeholders and to FSPs, CRO and collaborative groups on technical solutions to ensure high quality data collection and delivery. Deliver on solutions as needed
- FUNCTIONAL EXCELLENCE: Collaborate and contribute to functional/cross-functional initiatives or goals to promote new ways of working, including emerging technologies. Enable broader and more effective use of data to support the business
- Led CDM study teams, overseeing all start-up, conduct, and close-out activities for multiple complex studies, ensuring fit-for-purpose quality in collaboration with FSPs, vendors, CROs, and collaborative groups.
- Experience with SDTM implementation and CDISC standards
- STAKEHOLDER MANAGEMENT: Proactively engage with stakeholders across the business to understand their needs and influence their understanding of decisions made in our function. Inform stakeholders of status of key deliverables and act on changing milestones
- Organized and integrated data from various sources, maintaining its value through application of FAIR (Findable, Accessible, Interoperable, Reusable) principles.
Senior Study Data Manager
Genentech, Inc. A Member of the Roche Group
South San Francisco, USA
03.2011 - 05.2019
- Coordinated oversight of study data review and discrepancy management to ensure data integrity and compliance.
- Ensure data cleaning in conjunction with Science, Medical Coding, and Data Acquisition to ensure the high quality clinical data extraction for data analysis
- Effectively communicate study goals and status of work, including all requirements to CDM study team and stakeholders
- Identify gaps in Study Data Manager (SDM) knowledge and provide coaching and mentoring on sub functional activities to SDMs and/or raise gaps to Program Data Leader (PDL) and CDM Management
- Foster partnership, teamwork and collaboration, develop and maintain working relationships within and outside CDM at the study level
- Lead proactive sharing of knowledge using relevant forums and communication tools
- Executed database freeze procedures to ensure compliance and secure locking of study databases for SMT/PET.
- Actively supported the function by leading non-study responsibilities to optimize functional processes and assist colleagues.
Study Data Manager
Genentech Inc.
South San Francisco, USA
11.2010 - 03.2011
- Lead the CDM study team and maintain oversight of all activities for one or more studies
- Define scope of work and direct PDM activities outsourced to CROs/FSPs, ensuring alignment with project management principles
- Demonstrate a program-level understanding and have oversight to CDM issues, activities and deliverables
- Coordinate design of data collection instruments; create and maintain study data quality documents; track and communicate overview of study data quality and data flow status ensuring reconciliation of clinical data originating from different sources
- Provide data collection training to Investigators and site staff, working with them and their monitors to ensure their patient’s clinical information is captured fully and accurately
- Set targeted timeframes for deliverables, anticipated potential timeline delays, and negotiated outcomes to maintain project schedules
- Evaluate probability, impact and priorities of risks and develops and implements mitigation plan
- Develop contingency plans to mitigate risks, analyze strategy effectiveness, and monitor risks across studies within the defined program
- Effectively communicate ideas, project goals and status of work and independently present at department meetings
- Provide technical coaching and mentoring on sub-function activities to Study Data Managers (SDMs)
- Coach/mentor SDMs on PDM standards, work aids and guidelines and implements them consistently across studies within the project
Senior Clinical Data Associate
Gentiae Clinical Research Inc.
San Bruno, USA
06.2006 - 02.2007
- Interacted with clinical project teams to execute study start-up, maintenance, and close-out activities in alignment with sponsor and protocol requirements, and adherence to regulatory and company guidelines
- Reviewed and validated all project-generated data, reconciling external data to ensure completeness, accuracy, and logical consistency
- Perform database and transfer file quality control procedures; format and organize data to support clinical review and statistical analysis
- Work collaboratively with Clinical Programmers and Sponsors to develop data transfer specifications and edit checks implementations
- Coordinate data management workflow for assigned projects
- Develop project-specific data management plans as guidelines for conducting project activities
- Supported documentation, testing, implementation, and validation of regulatory-compliant systems and programs in clinical data management activities
- Assist in review and development of SOPs and process guides
- Support internal and sponsor audits to ensure compliance with SOPs, Good Clinical Practices (GCPs) and industry standards
Clinical Data Associate
Gentiae Clinical Research Inc.
09.2005 - 05.2006
- Perform review of routine clinical data to ensure completeness, correctness and consistency
- Coordinated discrepancy management process, identifying, generating, tracking, and resolving routine queries to enhance data accuracy
- Assisted in project-specific database design activities, performed user acceptance testing and validation to ensure data integrity, documenting all steps and findings
- Tracked and confirmed receipt of data, maintained detailed data inventory and processed status reports, assisting in managing data flow between investigative sites, vendors, and sponsors
- Act as supportive member of Clinical Project Teams for assigned projects and stand for project lead Clinical Data Manager in case of absence
- Supported team objectives through engagement in various special projects.
Cancer Data Assistant
California Pacific Medical Center
San Francisco, USA
02.2004 - 09.2005
- Conducted case finding to ensure accurate identification of reportable cases for data integrity
- Maintain cancer registry follow-up data in computerized database
- Coordinated mailings to collect follow-up data from registry patients, facilitating comprehensive data acquisition
- Handle internal and external requests for follow-up information
- Provide administrative support for weekly cancer board and cancer committee meetings
- Assisted in special projects by coordinating tasks and resources to support project objectives
Perinatal Data Clerk
California Pacific Medical Center
San Francisco, USA
06.2002 - 02.2004
- Collect and enter patient data for perinatal data center
- Interviewed patients daily to gather information for accurate generation of birth and fetal death certificates
- Coordinated with Social Services, Department of Public Health, and mortuaries to process Fetal and Neonatal Death Certificates and disposal permits efficiently
- Ensured reliability of perinatal statistical and demographic database to support accurate reporting and analysis.
- Generated daily and monthly reports to support decision-making across various departments
Education
B.S. - Business Administration- Computer Information Systems
San Francisco State University
San Francisco01-2002
Skills
- Clinical Data Management
- Medidata Rave EDC
- TIBCO Spotfire
- Data Visualization
- Advanced analytics
- Study build design
- Data standardization practices
- Metrics tracking
- Data review
- Project management
- Vendor oversight
- Stakeholder management
- Team management
- Team development
- Process optimization
- Strategic planning
- Innovation strategies
- Clinical practice standards
- Therapeutic area knowledge
- Problem solving
- Team collaboration
Affiliations
- Society for Clinical Data Management, 01/01/07, Present
- Drug Information Association, 01/01/07, 12/31/21
Certification
- Clinical Trials Design & Management Certificate in Biotechnology, San Francisco State University-College of Extended Learning, 05/01/05
- Basic Cancer Registrar Training Program Certificate, The Northern California Cancer Center, 10/01/04
- Introduction to Oncology and Chemotherapy, Healthcare Education Services, 10/01/08
Timeline
Principal Data Operations Leader
Genentech, Inc. A Member of the Roche Group
11.2023 - Current
Principal Data Sciences Product Leader
Genentech, Inc. A Member of the Roche Group
10.2022 - 10.2023
Senior Data Sciences Product Leader
Genentech, Inc. A Member of the Roche Group
06.2021 - 09.2022
Senior Data Manager
Genentech, Inc. A Member of the Roche Group
06.2019 - 05.2021
Senior Study Data Manager
Genentech, Inc. A Member of the Roche Group
03.2011 - 05.2019
Study Data Manager
Genentech Inc.
11.2010 - 03.2011
Senior Clinical Data Associate
Gentiae Clinical Research Inc.
06.2006 - 02.2007
Clinical Data Associate
Gentiae Clinical Research Inc.
09.2005 - 05.2006
Cancer Data Assistant
California Pacific Medical Center
02.2004 - 09.2005
Perinatal Data Clerk
California Pacific Medical Center
06.2002 - 02.2004
B.S. - Business Administration- Computer Information Systems
San Francisco State University