RBQM Implementation Consultant(Remote)

United States, NY, New York

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 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.

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:

  • 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 (e.g., 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 (e.g., 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, e.g., process improvement, product improvement, and identifying best practices
  • Comply with Medidata SOPs and procedures
  • Manage a customer facing project

Your Competencies:

  • 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

Your Education & Experience:

  • 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

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 NYC Metro Area is $79,500-85,314.

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 are hired for an in-person 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, such 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.



Diversity statement

As a game-changer in sustainable technology and innovation, Dassault Systèmes is striving to build more inclusive and diverse teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future.

Equal opportunity

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at 3DS are based on merit, qualifications and abilities. 3DS is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age (40 and above), disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. 3DS will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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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.