William He

Responsible for program and portfolio management in R&D stage.

Responsible for program and portfolio management in product development stage.

Responsibilities include: 1) Based on seniority, Senior Project Manager plans, drives and executes trial level project management activities for assigned studies of different scopes (Ph1 to Ph3, FIH, PK, etc); including trial level timelines, risk assessment, mitigation plans and other aspects of trial level project management (e.g. budget, metrics) 2) Leads cross-function study team meetings. 3) Develops and tracks overall trial operational plan, timeline and gains alignment with affiliates and team members on milestone dates. 4) Ensures quality & data compliance at the trial level to achieve country and site level compliance, as appropriate 5) Manages relationships and serves as the focal point of communication between internal and external clinical research partner at the trial level. 6) Productively identifies and communicates appropriately the status of ongoing projects, Issues, and risks that may affect the critical path of the clinical trial and project schedule. 7) Drives and reviews sourcing alternatives, provides necessary study specific actions in order to obtain reliable study costs, staffing strategy, and timeline projections. 8) Provides oversight of CRO performance throughout study implementation if applicable 9) Coach field monitors/Lead CRA/CRAs by trial needs. Develops study training and may also coordinate/deliver training, as appropriate. 10) Obtains clinical trial cost forecasts. Establishes and monitors the trial budget. 11) Drives, manages and tracks trial enrollment 12) Coordinates proposal reviews with third party vendors, and provides input regarding needed changes in contract conditions. 13) Responsible for trial quality, contribute to trial quality plan with QC team. Set up risk mitigation plan, and anticipates, manages and escalates issues as appropriate. 14) Maintains and archives at trial level documentation. 15) Partners with study team in the management of data locks (final and interim) and site closure

Acts as primary liaison with client; Leads and directs cross-functional team leaders and third parties/vendors; Manages project contractual deliverables; Manages project costs; Ensures adherence to company SOP, policies and guidelines at the project level.

Acts as primary liaison with client; Leads and directs cross-functional team leaders and third parties/vendors; Manages project contractual deliverables; Manages project costs; Ensures adherence to company SOP, policies and guidelines at the project level.

To take full study management roll for 1 local study with 20 sites invloved in China

Contract CRA to GSK from a local CRO company