Medidata Solutions

Associate Implementation Consultant Client Services Iselin, New Jersey Apply Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial and real-world data. Powered by artificial intelligence and delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata serves more than 1,000 customers and partners worldwide and empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: ************* We know that diverse teams win and are fully committed to selecting leaders and employees that represent the markets in which we operate. 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 2000 employees. Your Mission: Associate 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. Your Competencies: 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 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 way Your Education & Experience: 4 -year college degree or equivalent (analytic discipline a plus) 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. EEO Statement US: 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. #LI-CD1 Associated topics: business, business advisory, business analysis, business intelligence, business systems, client, consult, market, sap, support analyst

Senior Application Engineer Technology & Analytics San Mateo, California Apply Medidata's unified platform, pioneering analytics, and unrivaled expertise power the development of new therapies for over 1,000 pharmaceutical companies, biotech, medical device firms, academic medical centers and contract research organizations around the world. The Medidata Clinical Cloud connects patients, physicians and life sciences professionals. Companies on the Medidata platform are individually and collaboratively reinventing the way research is done to create smarter, more precise treatments. For more information: *************. We know that diverse teams win and are fully committed to selecting leaders and employees that represent the markets in which we operate. 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 2000 employees. Your Mission: The Senior Software Engineer Function is responsible for hands-on development of Medidata's software applications. The Engineer is one who works very quickly to resolve high impact, challenging, engineering problems while continuously raising the standard of quality in our products and services in a full solutions-oriented SaaS environment. - Provide estimates in backlog grooming - Identify tasks in planning - Contribute to scenario writing - Actively contribute at retrospectives - Participate in experimental changes in technical improvements and/or processes arising from retrospectives - Apply simple platform design principles locally - Extend service contracts - Apply BDD/TDD. Apply simple patterns - Be aware of the impact of design on performance, e.g. through algorithmic complexity, N+1 fetching, etc - Competent in tech stack of choice - Deliver new areas of functionality - Review pull requests for functional aspects - Perform local refactoring when making changes - Contribute to continuous integration pipeline - Contribute to addressing technical debt - Identify root causes - Create fixes with unit tests where appropriate - Provide technical impact assessment - Create unit tests and step definitions for test automation where appropriate - Modify and troubleshoot automated deployment implementation - Access production monitoring - Diagnose issues while dealing with initial uncertainty and incomplete information - Provide feedback on documentation - Communicate personal and team activities to those outside the team, e.g. blog posts, presentations, stakeholder demos - Attend all appropriate team meetings - Attend company-organized meetups Your Competencies: - Enjoy working in multiple programming languages on a day to day basis. In addition to working on highly optimized server-side Java code you may find yourself working on some problems in Ruby and Javascript - Constantly seeking to be an expert and takes pride in self-mastery and knowledge development. Quick learning and applied-knowledge capability - Thrives in a team environment, and has strong people communication skills - Enthusiastic and passionate about developing and improving products. Be explorative on creative solutions and technology in the industry that will help products to grow to next evolution. - Have an innate ability for communicating very high level technical information to a non-technical audience, especially upper management and customer facing groups - Able to use disparate pieces of information to drive investigation and problem solving. Especially in situations where there may not be very much information available on the problem, and you have to use your own creativity or teamwork to drive investigation and devise an appropriate fix - Take ownership of technical projects and provide leadership among peer developers to execute technical implementation through the life-cycle of projects. - Demonstrated expert-level experience in troubleshooting and debugging web server platforms, software and code - Sufficient prior background in web software development is necessary for the position - Ninja-like data querying abilities in SQL(MySQL) and/or NOSQL(MongoDB, Cassandra, Redis, etc) - Have Best-of-Breed problem solving abilities and enjoy crafting technical solutions that are business and customer driven - Have the ability to plan, design and implement code fixes on multiple, unrelated sections of the codebase, and/ or different products altogether - Take pride in knowing that the solutions you craft today are helping to develop new medicines that shape the world of tomorrow - In-depth understanding of Java SDK Framework is a required element of the position - Knowledgeable with Angular.js, React.js, or equivalent Front-end framework is required - Basic prior experience in working with cloud technologies such as Amazon Web Services is preferred (e.g. S3, EFS, Lambda, SQS, etc) - Basic understanding of GitHub, Jira and Jenkins Your Education & Experience: Typically requires a minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; Prior experience from on commercial B2B / Enterprise SaaS offerings, involving documents and/or workflow / process - The minimum education level required (Bachelor's, Master's, etc.) - The fields of study you would accept (Computer Science, I.T., etc.) - The minimum years of experience you require overall - The minimum years of experience you require in specific tasks, technologies, types of experience etc. Note: The requirements should reflect your minimum requirements for the role in general 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. EEO Statement US: 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. #LI-AT1 Associated topics: .net, architecture, backend, design pattern, develop, expert, matlab, perl, project architect, senior

Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial and real-world data. Powered by artificial intelligence and delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata serves more than 1,000 customers and partners worldwide and empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: www.mdsol.com We know that diverse teams win and are fully committed to selecting leaders and employees that represent the markets in which we operate. 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 2000 employees. Your Competencies:* Use deep clinical/EDC data knowledge and QC procedures to QC SDTM and ADaM datasets.* Map the data elements from raw clinical trials data files to standard variables* Search study specific EDC datasets to look for patients that meet certain criteria* Read and interpret results of clinical trials on publicly available sources such as clincialtrials.gov, PubMed and FDA website.* Review standardizations across thousands of trials from multiple sponsors and make recommendations.* Use analytic programming tools (SAS or R, in house) to do exploratory data analysis.* Document and summarize QC results for statisticians, data engineers, and project managers.* Run, review, publish, and support automated data summaries. Your Education & Experience:* BA/BS, Master's degree in life science or a quantitative discipline required.* Minimum 5 years working with clinical data including hands-on work in, and deep knowledge of, all of the following:* Clinical trials data collection design and process (eCRF, EDC)* Clinical data QC processes and methods, including statistical and programmatic approaches* Analysis of subject-level clinical data* Requires intermediate skills in SAS or R or Python for data exploration. * Good documentation, communication and interpersonal skills.* Ability to explore clinical datasets and complex scientific documents and make sophisticated judgments about meaning of, and patterns in, data.* Prefer experience/knowledge of SDTM and ADaM standards.* Prefer work experience at multiple pharmaceutical research companies.* Prefer experience with oncology trials. 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. EEO Statement US: 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. #LI-AS1 Associated topics: data administrator, data analytic, data engineer, data integration, data integrity, data management, data warehouse, sql, sybase, teradata

Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial and real-world data. Powered by artificial intelligence and delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata serves more than 1,000 customers and partners worldwide and empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: www.mdsol.com We know that diverse teams win and are fully committed to selecting leaders and employees that represent the markets in which we operate. 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 2000 employees. Your Mission: We have an opportunity for a strong agile Sr. Project Manager to join our team in NYC, developing clinical cloud solutions at Medidata. As this is one of our key solutions, you will be used to managing software development in mid/ large teams. Monitors the project from initiation through delivery including planning and directing schedules and monitoring budget/spending. Organizes cross-functional activities, ensuring completion of the project i.e. product on schedule and within defined timelines. The Project Manager will also work across the portfolio with Product Managers, functional stakeholders and management to ensure standardized processes are established across the software development lifecycle and release management to drive the development of high quality, high value software products within an Agile environment. Project Management * Full accountability for the management of project timelines, scope and milestones for one or more projects. * Manage the complete Software Development Lifecycle. * Serve as the primary interface between Product Management, Research and Development, and IT on deliverables, timelines, priorities and issues regarding the project. * Oversight of one or more vertical teams in the agile environment. Pro-active communication with all stakeholders. * Oversee product releases of your assigned project(s) by coordinating Engineering, Software Quality Assurance, Technical Communications, Knowledge Management, Internal Compliance, Application Support, Delivery Services, Operations, Sales, Marketing, Reporting, and Technical Communicators. * Anticipate risks to your assigned project(s) and across all portfolios/projects and communicate these risks/issues to management, and offer creative solutions. * Responsible for deliverables including project plans, issues lists, status reports, and meeting agendas with action items. * Responsible for the tracking documentation, including specifications, validation plans, installation/operational/performance qualifications, validation summaries, etc. * Maintain up-to-date knowledge of core products. Agile / Scrum Responsibilities: * Schedule and facilitate daily SCRUM meetings with the agile teams to review cross-project progress and issues, including deliverables and action items. * Schedules and leads the sprint planning and release planning exercises. PM will facilitate the brainstorming sessions (backlog grooming during each sprint). * Leads product teams in adopting Agile / Scrum methodology via training and coaching. PM will encourage self-organized teams, but is accountable for Agile usage. Your Competencies: * Communication Skills: * Clearly communicates with team Active participant in discussions Can successfully lead discussions when expected to do so Has excellent written skills. Can create presentation materials. * Leadership Skills: * Viewed as a competent, valued contributor to the team Capable of guiding/leading meetings and discussions Your Education & Experience: * Minimum of 5 years of software development and/or project management experience is required * Background in applying rigorous project management practices preferred * Scrum Master Certification preferred, * PMI certification (for example, PMP or PMI-ACP Certification) is preferred 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. EEO Statement US: 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. SDL2017 Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task