China - SH, Shanghai
Medidata: Power Smarter Treatments and Healthier People
Medidata, a Dassault Systèmes company, is leading the digital transformation of life sciences, creating hope for millions of people. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Known for its ground-breaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. And Medidata’s ongoing commitment to infusing the patient voice into trial designs and solutions is helping to create a better and more inclusive experience for all participants in clinical studies. Medidata is involved in nearly 40% of company-initiated trial starts globally, with studies conducted in more than 140 countries. More than 70% of novel drugs approved by the Food and Drug Administration (FDA) in 2022 were developed with Medidata software. Medidata is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @medidata.
Implementation Consultants (IC) help ensure that Medidata’s software applications are implemented and configured in accordance with Medidata standard business processes, meet client requirements and adhere to Good Clinical Data Management Practices. IC’s also consult with our clients, provide guidance and make suggestions on how to best implement Medidata’s software to provide the most value.
The Implementation Consultants work with Project Managers and other functional departments during the implementation and configuration of Medidata’s software applications for clinical studies, in addition to helping in the training, education and mentoring of colleagues who are new to working with clinical trials. The IC will be the primary resource for authoring specification documents and used by different groups as well as configuring study design during the development of clinical studies using Medidata’s suite of products.
- · Advise external customers and internal staff on best practices for implementing Medidata’s software
- · Work with Project Managers in translation of customer needs in terms of system functionality to ensure a match between needs and actual system capabilities/limitations
- · Work directly with the client to prepare, adapt, or agree on all specifications provided by the client
- · Ensure that Clinical Services functions are aligned and meet Project Management timelines and deliverables
- · Assist in the scheduling of professional services resources and ensure timely completion of deliverables
- · Define and enforce data collection and handling standards on all deliverables to ensure consistency and facilitate downstream processing (e.g., QC testing)
- · Coordinate and support developers during study development
- · Author specifications based upon client requirements, including functional test cases, for use in configuring and developing solutions in Medidata’s suite of products as well as in custom integrations with other products
- · Configure Medidata software products to meet customer requirements
- · Support Training Group in preparation of course materials and delivery of courses both internally and externally (e.g., clinical sites and investigator meetings) as needed
- · Support custom integrations to ensure final product meets customer requirements
- · Support customer during user acceptance testing cycle by resolving issues, answering questions, and guiding them through the process
- · Work with third party vendors such as central labs to ensure that all back-end clinical data changes follow best clinical data management practices
- · Work with Quality Control department when needed on clinical software projects
- · Provide written and verbal status reports to management on client projects and internal projects.
- · Participate in internal initiatives, e.g., process improvement, product improvement, and identifying best practices
- · Comply with and enforce Medidata SOPs, procedures, and policies
- · Own a customer facing project
- · Knowledge of Clinical Trial processes, specifically as they related to data collection, management, and preparation for statistical analysis
- · Strong understanding of data management plans/customer specifications for data entry screens, edit checks, custom reports and data integrations
- · Ability to work with technical R&D staff and translate new software features into real world examples
- · Knowledge of computer usage in a web-based environment
- · Ability to think logically to solve complex problems
- · Excellent verbal and written communication skills, organizational and time management skills
- · Solid analytical and technical skills with regard to software applications
- · Strong collaboration and team-building skills
- · Self-motivating, able to assume responsibility and work autonomously in a professional manner
- · Responsible for execution and delivery
- · Native level local language and business level English required.
Your Education & Experience:
- 4 -year college degree required (analytic discipline a plus)
- 1-3 years relevant experience in clinical/biomedical and/ or software development environment
- Electronic Clinical Data Management (eCDM) software consulting experience desirable
- Good experience working with clinical trials in a data management-related role, or equivalent combination of education and experience
- Experience supporting project teams and meeting project timelines