Implementation Consultant (Regulated Content Management)
Medidata: Conquering Diseases Together
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 1,400 customers and partners access the world's most-used 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.
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 is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform.
Medidata’s solutions have powered over 14,000 clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner.
Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.