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 Decentralized Clinical Trials (DCT) Project Manager helps Medidata's customers learn and adopt Medidata technologies for DCT implementations in accordance with Medidata and customer standard business processes, meet client requirements and adhere to Good Clinical Data Management Practices. DCT PMs are supported by Implementation Consultants to partner with our clients, provide guidance and make suggestions on how to best implement Medidata’s software to provide the most value while ensuring viable readiness before, during, and after deployment of Medidata technologies and services.
DCT PMs work with Implementation Consultants and other functional departments during the implementation or enablement of Medidata Software Applications, in addition to helping in the training, education, and mentoring of colleagues. DCT PMs are leaders of client and internal colleagues, as well as champions of our products and processes.
Your Key Responsibilities:
- Lead coordination of plan, design, build, test & run phase activities for DCT solutions.
- Build and maintain client relationships by providing guidance and consulting to clients around the best use of the Medidata Applications for DCT strategies.
- Coordination with cross-functional teams to drive client communications and expectations and ensure timely delivery of DCT studies.
- Partner with Product Management & Development in ideation of future platform enhancements and associated priorities with a balanced value view of innovation and customer demand.
- Comply with and enforce Medidata Standard Operating Procedures, processes and policies.
- Support optimizing execution control standards to serve the best Customer, Site and Patient experiences.
- Advise and mentor customers during implementation
- Establish “Trusted Advisor” relationship through effective consultation
- Advise external and internal customers on best practices for implementing Medidata’s software
- Ensure that clinical services functions are aligned and meet project management timelines and deliverables
- Provide support for implementation projects as assigned
- Provide feedback from customers to Medidata Product and Services on desired features and functionality that continuously improve service to our customer
- Contribute to SOP and SWI Development for DCT Services
- Attend key operational meetings in support of Medidata applications
DCT PMs are responsible for maintaining a high-level of expertise for their assigned Medidata Products. They are expected to participate in the following key internal Medidata activities:
- Maintain individual Product and Industry expertise by attending regular Product Training and external industry training, e.g. conferences.
- Represent Professional Services Partner’s team in Product Adoption and Optimization (PAO) workstreams and initiatives; sharing knowledge back to the full Partner Professional Services team
- Support training of wider Professional Services team to enhance Product and Industry knowledge across team
- Collate and maintain list of defect and enhancements that require addressing by Medidata Product teams
- Provide operational insight to defect and enhancement requests
- Provide operational input to Medidata’s implementation process, best practices and collateral roadmaps ensuring that Professional Services team is represented
- Ensure SOPs and other process documents are up to date with any specific activities related to CRO Partners
- Work with Medidata Academy on the development of training plans and collateral Your Competencies:
The successful candidate will have:
- Proven experience working with clinical trials in Technology/Services consulting or lead delivery role
- Proven ability to deliver training to clinical and technical resources internally and externally
- Proven ability to learn new technologies and associated features quickly and translate that into standardized artifacts for training and execution control
- 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
- Ability to think logically to solve complex problems
- Excellent verbal and written communication skills, organization, and time management skills
- Solid analytical and technical skills tied to SaaS 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
- Ability to challenge processes that are inefficient or counterproductive and establish/deploy new processes to improve efficiency, strong change management, and collaboration skills In addition, the candidate will:
- Be self-motivated
- Proven ability to successfully work independently on new projects and initiatives while also being able to collaborate with others when needed to achieve goals
- Seen to take initiative and demonstrate responsibility
- Demonstrated practical knowledge of clinical trial software technology
- Strong interpersonal, organizational, communication (public speaking and teaching), presentation and writing skills
- Ability to overcome obstacles, troubleshoot and reach resolutions
- Collaborate well with other functions/departments
- Willingness for up to 30% national/international travel time
Your Education & Experience:
- Minimum 4-year university/college degree or equivalent (analytic discipline a plus)
- Minimum of 5 years experience working with clinical trials, or equivalent combination of education and experience required.
- Minimum of 2 years of experience in project management
- 1+ Years’ experience using SaaS platforms to deliver Customized Solutions
- 1-3 Years Consulting experience in Digital Enablement or Equivalent
- 1-3 Years’ experience delivering Professional Training Services
- Leading change & strategic thinking
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.
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.
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at 3DS are based on merit, qualifications and abilities. 3DS is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age (40 and above), disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. 3DS will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Our Company requires all U.S. employees to be fully vaccinated against COVID-19 and to provide documentation of full vaccination, unless qualified for a medical, religious or state-required accommodation or otherwise exempt 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 due to customer requirements, staffing needs, or other business reasons. Definition of full-vaccination: Employees are considered to be fully vaccinated two weeks after their second dose in a 2-dose series or two weeks after a single-dose vaccine.