Clinical Operations Program Associate Manager

The Clinical Operations Program Associate Manager (COPAM) supports for the activities on a program and compound level, and is mainly accountable for providing oversight to cost and resource, optimizing the process of global clinical trial design and execution strategies across studies.

Additionally, this role also accountable for maintaining dashboards and matrices to the China-led or China alone studies.

The role holder supports delivery of clinical programs in the GMD area of responsibility & potentially supporting the delivery of programs within the ECD area of responsibility.

Take responsibility and act as change agents for building and developing the Clinical Operations Program organization, processes and technology related to delivery of clinical studies or other core activities in GMD.

• PMO, project management office
• Maintain China-led study dashboard and matrix
• Responsible for change control maintenance for China-led studies including but not limited to:
• Monthly track of program level resources and budget
• Monthly track of global DO resources, specifically China DO
• Variation review/endorse with GPD on monthly basis
• Responsible of PLANIT set up and maintenance including
• Collaborating with Global Project Manager (GPM) to set up a new study under PLANIT for development operations
• Monthly progress confirm for ongoing studies/program
• Build TA template in Merlin and feasibility study
• Develop a TA-specific template in Merlin for any new study to easily copy and use
• Build TA feasibility database based on global feasibility analysis from every study (including ClinOps hurdles, country start-up projections, KEE sites, country RR assumption, etc.)
• Responsible of global IB maintenance support by
• Providing program/study level progress and Reviewing updated progress content
• Obtain endorsement from GPD on proposed IB update
• Facilitate group meeting including but not limited to GPD team meeting and other LT review meetings
• Monitor GPD group resource and allocation