Responsibilities include but are not limited to: Main responsibilities involve study level project management support which includes the following activities: 1、Coordinate the end to end process for executing observational or non-interventional research studies (including Post Marketing studies and other regulatory commitments), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs). This includes planning/initiation, execution, and close-out of primaly data collection, chart review, database, and molecular epidemiology studies in addition to other activities (e.g.literature reviews, dossier development, etc.). 2、Supportthe Lead Scientists in overall operational support for study conduct. 3、 Main responsibilities involve study level project managementsupport which includes the following activities: 1) Assistin managing study level budget which includes forecasting, tracking invoices/spend, and communicating with stakeholders such as Finance, Legal, Risk Management, etc 2)Draft scope of work, and facilitate the execution of appropriate service, confidentiality, and consultant agreements and subsequent amendments/change orders 3)Coordinate internal/external meetings and draft/review agenda/minutes 4)Coordinate the review and finalization of all vendor documents such as the safety management, data management, and project management plans 5)Track timelines/deliverables and follow up on action items 6) Liaise with outsourced vendors and cross functional teams to communicate and oversee project status and/or needs 7)Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements 8)Collaborate extensively and trouble shoot issues by providing potential resolutions when necessary with internal and external partners to ensure timely management and execution of studies 9)Participant in or familiar with inspection 4、 Participate in protocol and interim/final reports preparation and literature review abstraction and summarization 5、Manage poster and publication development including: formatting, medical writing, figure/data content, and internal review process.
Qualifications Education: 1、 Master degree in Public Health (or closely related discipline, such as health administration or biological sciences) preferred 2、 CRA working experience is required, APM working experience is preferred
Required Experience and Skills: 1、Two or more years of work experience within observational research or equivalent experience 2、Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders 3、Basic knowledge of epidemiologic or outcomes research 4、Strong project management and prioritization skills 5、 Highly motivated, able to work independently and collaboratively within tight timeline 6、 Accept business travel (10%-20%)