Clinical Operations Program Associate Manager
AstraZeneca
- 上海市静安区
- 长期
- 全职
- 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
- Bachelor degree or equivalent in medical or biological sciences or discipline
- At least 5 years relevant clinical research experience in the pharmaceutical industry, academe or CRO, with 2-year experience of global clinical studies; ideally at least 2 years in a GSAM role (for internal candidate only)
- Advance knowledge of clinical research processes and regulatory requirements
- Demonstrated abilities in key clinical study management/drug development process
- Effective communication and advanced interpersonal skills with internal and external co-workers and stakeholders, including external service providers
- Demonstrated ability to collaborate as well as work independently
- Advanced computer proficiency and relevant project management/digital health tools in day-to-day tasks
- Fluent verbal and written communication in English
- Ability to manage competing priorities
- Advanced degree in a scientific discipline
- Demonstrated good project management skills in own assigned area/scope/process or with low-to-medium complexity to drive results
- Ability to execute team leadership
- Experience in all periods of a clinical study lifecycle, from setup, maintenance and close-out
- Ability to increase productivity and innovation within assigned area(s)
- Ability to recognize opportunities for new ways of working