Senior Implementation Consultant United States
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: 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.
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
- 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:
- Bachelors degree required
- Master 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
- 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.
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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