Data Services Senior Implementation Consultant
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.
The Data Service Senior Implementation Consultant , help ensure that Medidata’s software applications are implemented or enabled in accordance with Medidata standard business processes, meet client requirements and adhere to Good Clinical Data Management Practices. SICs also consult with our clients, provide guidance and make suggestions on how to best implement Medidata’s software to provide the most value.
The SICs work with Project Managers and other functional departments during the implementation or enablement of Medidata’s software applications, in addition to helping in the training, education and mentoring of colleagues. SICs are leaders of clients and internal colleagues, as well as champions of our products and processes)
Support planning and conduct of eCOA clinical studies across the phases (I-IV)
Provide solid Data Management expertise and guidance during decision making and/or issue resolution process
Contribute to cross-functional expectations on data quality and data cleaning activities incorporated into the Data Management Quality Plan
Provide ongoing data cleaning to identify issues/risks in data quality and data cleaning performance
Support and maintain strong alliances with other functions and with CRO partners
Discuss and design project specific technical solutions which support the data management plan
Continuously improve Data Management service processes and data quality measures
Deliver high quality Clean Databases
Is a member of the client team and internal study team and lead relevant discussions
Contributes to a transparent benchmarking of Data Management activities within function and study team
Initiates the DTS package and contributes to the set-up and testing of the eCRF incl. Edit Checks, data listings, and reports, in close cooperation with study team
Serves as the key subject matter expert and project lead on implementation topics related to data management activities. (e.g. mentoring junior staff, training team members, leading or contributing to expert working groups)
Deep experience in clinical development, especially demonstrating expert knowledge of strategy, operations, and analytics within the Clinical R&D space
Expertise in study planning and optimization, and knowledge across eCOA clinical development practice areas/technologies as a whole
Demonstrated ability to drive, delegate, and deliver multiple, (manage) complex projects and projects to success
Strong, clear communicator with ability to consult confidently ; has good command of public speaking and presentation skills
Your Education & Experience:
Minimum 4-year university/college degree or equivalent (analytic discipline a plus) experience with a minimum of 5years of experience
3+ years related eCOA experience
5+ years in Clinical Data Management
Multi-year experience working with clinical trials, or equivalent combination of education and experience required.
Prior data management or clinical trial software consulting experience preferred.
Demonstrated experience leading and 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.