Implementation Consultant - EDC
Our Industry: Where we play
Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development. Our work ensures that life-saving drugs and medical devices get to market faster. We are a certified “Great Place to Work” with highly engaged employees focused on improving the health outcomes of patients across the globe.
We develop cloud-based enterprise products and services and are a world leader driving the convergence of the Technology and Life Sciences industries, one of the most exciting areas for innovation globally. With annual revenue in 2016 of nearly $500 million, we are publicly traded (MDSO) with over 850 customers and customer retention rates above 99%. The Medidata Clinical Cloud® is the primary technology solution powering clinical trials for 18 of the world's top 25 global pharmaceutical companies and is used by 18 of the top 25 medical device developers—from study design and planning through execution, management and reporting. Our customers include global pharmaceutical companies, biotech, diagnostic and device firms, leading academic medical centers, technical partners and contract research organizations.
By automating over 12,000 clinical trials to date, Medidata has the largest collection of clinical trial data in the world. Today, Medidata pioneers innovative, advanced applications and intelligent data analytics, bringing a new level of quality and efficiency to clinical trials. That means better treatments reach waiting patients sooner.
We know that diverse teams win. It is our diversity and inclusiveness that fuels innovation and sparks our passion and commitment to patient health. We are still led by our Co-founders, Tarek Sherif and Glen de Vries, and have global operations in US, Europe and Asia with over 1900 employees.
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 Preferred Competencies:
(list ‘ideal’ technical/functional competencies - Knowledge, Skills, Abilities)
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
Our Culture: Who we are
We know that creativity doesn't happen on-demand. Developing cutting-edge cloud technology takes great minds and talented people working together in a collaborative environment. That is why we are committed to fostering an innovative, agile company culture. We encourage our teams to come together and experiment with new concepts, research new approaches and test out new technologies. We believe that being part of our team will make a difference in the world.
Our Mission: Powering smarter treatments and healthier people.
Our Vision: To be the most innovative cloud company in Life Sciences.
Our Principles: Integrity, Partnership, Inventiveness, Humility, Nimbleness, Tenacity, Inclusiveness, and Caring.
Our Leadership Drivers:
• THINK: Inspires purpose, articulates strategy, and simplifies complexity
• TEAM: Communicates effectively, builds relationships and collaborates with others
• DO: Plans ahead, scales for growth, ensures accountability
• LEARN: Self-aware, values difference, strives to learn
• TEACH: Inspires work, coaches others, builds teams
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.
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