Senior Implementation Consultant

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.

Your Mission:

Senior 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. Senior 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 Senior 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 project, customer facing

• Responsible for execution and delivery

• Subject Matter Expertise (SME) and competencies across multiple products/solutions

Your Competencies:

• Good experience working with clinical trials in a data management-related role, or equivalent combination of education and experience

• Knowledge of Clinical Trial processes, specifically as they relate 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, organization and time management skills

• Solid analytical and technical skills with regard to software applications

• Experience supporting project teams and meeting project timelines

• 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:

• Bachelor's degree required

• Master's degree preferred (analytic discipline a plus)

• 5+ years relevant experience in clinical/biomedical and/ or software development environment

• Prior professional services project financial experience required

• Prior services delivery experience required

• Electronic Clinical Data Management (eCDM) software consulting experience desirable

 Medidata requires all U.S. employees to be fully vaccinated against COVID-19 and to provide documentation of full vaccination, unless qualified for an accommodation as determined by Medidata, consistent with applicable law. Although accommodation requests will be considered (and granted where appropriate/possible), it may be determined that a candidate is unable to adequately perform the essential functions of the position without imposing an undue hardship on Medidata due to customer requirements, staffing needs, or other business reasons.

#LI-TC1

#LI-Remote

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.