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Medidata: Power Smarter Treatments and Healthier People
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. 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 1,900+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, 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
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
MEDIDATA generates the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes.