Implementation Consultant, Data Quality & Risk Surveillance (DQRS)
About the Company:
Medidata: Powering 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 groundbreaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. 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 on LinkedIn, Instagram, and X.
Your Mission:
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 follow 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. IC's also promote 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 as well as configuring study design and training clients during the development of clinical studies using Medidata's suite of products.
You will report into the Manager of Client Services.
Main activities performed by the Professional Services Implementation Consultant will include:
- 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 provide 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 responsibilities are aligned and meet Project Management deliverables
- Help schedule professional services resources and ensure 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
Your Competencies:
- Knowledge of Clinical Trial processes, specifically as they related to data collection, management, and preparation for statistical analysis
- Experience with 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 of computer usage in a web-based environment
- Analytical and technical competency with software applications.
- Familiar with clinical database architecture, data structure and clinical database standardization
- Proficient in SDTM data standards
- Knowledge of data mapping and reporting
- Ideal candidate will come from a centralized monitoring and data analytics background
Your Education & Experience:
- University/college degree or equivalent(data management discipline a plus)
- Experience in clinical/biomedical and/ or software development environment preferred
- 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
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; a generous pension; and 25+ paid holidays per year.
Applications will be accepted on an ongoing basis until the position is filled.
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Diversity statement
MEDIDATA は、医薬品企業、バイオテクノロジー企業、医療機器企業、診断関連企業、学術研究者などが価値を加速し、リスクを最小限に抑えながら、結果を最適化するのに役立つエビデンスとインサイトを生成します。