- Advise external customers and internal staff on best practices for implementing Medidata's software
- Work with Project Managers and Operational Advisors in translation of customer needs regarding system functionality to ensure a match between needs and actual system capabilities
- Work directly with the client to prepare, adapt, or agree on all specifications provided by the client
- Ensure that Clinical Services responsibilities are aligned and meet Project Management deliverables
- Help schedule professional services resources and ensure completion of deliverables
- Establish data collection and handling standards on all deliverables to ensure consistency and facilitate downstream processing (, QC testing)
- Coordinate and support developers during study development
- Author specifications based on client requirements, including functional test cases, for use in configuring solutions in Medidata's suite of products and 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 (, clinical sites and investigator meetings)
- 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, , process improvement, product improvement, and identifying best practices
- Comply with Medidata SOPs and procedures
- Manage a customer facing project
- Knowledge of Clinical Trial processes, specifically as they related to data collection, management, and preparation for statistical analysis
- Understanding of data management plans/customer specifications for data entry screens, edit checks, custom reports and data integrations
- Work with technical R&D staff and translate new software features into real-world
- Experience In a web-based environment
- Collaboration and team-building skills
- Responsible for execution and delivery
- Familiar with clinical database architecture, data structure and clinical database standardization
- Proficient in SDTM data standards
- Knowledge of data mapping and reporting
- Centralized monitoring and data analytics background
- Minimum 4-year university/college degree or equivalent(data management discipline)
- Minimum of 2 years experience in clinical/biomedical 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
- Travel expectations up to 20%, domestic & international
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RBQM Implementation Consultant(Remote) - Vélizy-Villacoublay, France - Dassault Systèmes
Description
Your Mission:
Implementation Consultants (IC) help ensure that Medidata's software applications are implemented and configured following Medidata standard business processes, meet client requirements and adhere to Good Clinical Data Management Practices. IC's also consult with our clients and provide guidance on how to best implement Medidata's software to provide the most value. IC's also enable clients on the usage of Medidata's software application through training, education, and mentoring. The IC will be the primary resource for authoring specification documents and used by different groups and configuring study design and training clients during the development of clinical studies using Medidata's suite of products.
Main activities performed by the Professional Services Implementation Consultant will include:
Your Competencies:
Your Education & Experience:
As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location.
The salary range for positions that will be physically based in the California Bay Area is $84,000-112,000.
The salary range for positions that will be physically based in the Boston Metro Area is $78,000-104,000.
The salary range for positions that will be physically based in Texas or Ohio is $70,125-93,500.
The salary range for positions that will be physically based in all other locations within the United States is $71,250-97,729.
Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata's non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, dental, life and disability insurance; 401(k) matching; unlimited paid time off; and 10 paid holidays per year.
Medidata follows a hybrid office policy in which employees who live within 25 miles of a Medidata office are expected to work on site a certain number of days per week (with the specific in-office days to be designated by your team). On July 8, 2024, employees will be expected to work on site at least 2 days per week. This will increase to at least 3 days per week beginning January 2, 2025.
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