Requisition ID: 1805684734W
OVERALL PURPOSE OF JOB:
Medical Affairs RWE study Management
•Lead and work with medical colleagues to develop observational research in study plan and protocol design and statistical analysis of company sponsored study or collaborative study, investigator-initiated study.
•The Manager works cross-functionally to support the Content, tactical and execution of observational research across the portfolio.
•Collaborate with Global and Regional team on data generation strategy development and implementation in China
•Cooperate with medical & medical affair operation team to provide leadership and operational excellence for the execution and conduct of real world studies, responsible for the periodical report including issues identified and action plan.
•Manage and track the study timeline, study budget and products of company sponsored studies and collaborative study.
•Ensure the clinical studies are in compliance with local regulations, company SOPs.
•Establish and lead local review and tracking processes.
•Vendor selection and management if the outsourced service is needed.
•Ensure stringent compliance when fulfill the above responsibilities.
Medical Publication Management
•Establish the local working model for publication based on company SOP and local regulation.
•Oversee publication owned by Medical Affair and ensure the compliance.