北京招聘

Job Description13
The Epidemiology Department resides within BARDS, as a part of company Research Laboratories. Its research areas include epidemiology of disease, pharmacoepidemiology (drug and vaccine safety, effectiveness and utilization) and patient reported outcomes. The research conducted involves carrying out studies and activities, often in collaboration with outside investigators, to support epidemiologic needs applicable to all company products. The department also conducts research using numerous in-house and publicly available databases.13

Responsibilities include but are not limited to:13
Main responsibilities involve study level project management support which includes the following activities:
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.).
Supportthe Lead Scientists in overall operational support for study conduct.
Main responsibilities involve study level project management support which includes the following activities:
Draft scope of work, and facilitate the execution of appropriate service, confidentiality, and consultant agreements and subsequent amendments/change orders
Coordinate internal/external meetings and draft/review agenda/minutes
Coordinate the review and finalization of all vendor documents such as the safety management, data management, and project management plansTrack timelines/deliverables and follow up on action items
Assistin managing study level budget which includes forecasting, tracking invoices/spend, and communicating with stakeholders such as Finance, Legal, Risk Management, etc
Liaise with outsourced vendors and cross functional teams to communicate and oversee project status and/or needs
Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements
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
Utilize, manage, and maintain documentrepositories and internal/external systems (e.g. REDS, Spectrum, Veeva Vault, REV/OPS, SAP concur and EnCEPP)
Participate in protocol and interim/final reports preparation and literature review abstraction and summarization
Manage poster and publication development including: formatting, medical writing, figure/data content, and internal review process. Familiar with OSTIC and Datavision systems
Participate in quality control assessments and ensure integrity of study data for reports and publications


Education:13
Bachelor's degree required
Master degree in Public Health (or closely related discipline, such as health administration or biological sciences) preferred

Required Experience and Skills:13
Two or more years of work experience within observational research or equivalent experience
Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders
Basic knowledge of epidemiologic or outcomes research
Strong project management and prioritization skills
Highly motivated, able to work independently and collaboratively within tight timeline
Accept business travel (10%-20%)

默沙东（研发）中国有限公司诚聘