Clinical Data System Implementation Consultant

Company Name:
RM Staffing Associates
Our client, a leader in the Research and Development industry is seeking an experienced Rave study builder for their Edison, NJ location.
The Company's Implementation Consultants (IC) help ensure that company's software applications are implemented and configured in accordance with Company standard business processes, meet client requirements and adhere to Good Clinical Data Management Practices. ICs also consult with our clients to provide guidance and make suggestions on how to best implement Company's software to provide the most value. ICs work with Project Managers and other functional departments during the implementation and configuration of Company'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 Company's suite of products.

Key Responsibilities:

o Advise external customers and internal staff on best practices for implementing Company's software
o 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
o Work directly with the client to prepare, adapt, or agree on all specifications provided by the client
o Ensure that Clinical Services functions are aligned and meet Project Management timelines and deliverables
o Assist in the scheduling of professional services resources and ensure timely completion of deliverables
o Define and enforce data collection and handling standards on all deliverables to ensure consistency and facilitate downstream processing (e.g., QC testing)
o Coordinate and support developers during study development
o Author specifications based upon client requirements, including functional test cases, for use in configuring and developing solutions in Company's suite of products as well as in custom integration with other products
o Configure Company software products to meet customer requirements.
o 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
o Support custom integrations to ensure final product meets customer requirements
o Support customer during user acceptance testing cycle by resolving issues, answering questions, and guiding them through the process
o Work with third party vendors such as central labs to ensure that all back-end clinical data changes follow best clinical data management practices
o Work with Quality Control department when needed on clinical software projects
o Provide written and verbal status reports to management on client projects and internal projects.
o Participate in internal initiatives, e.g., process improvement, product improvement, and identifying best practices
o Comply with and enforce company SOPs, procedures, and policies


o 4 year undergraduate degree and 3 years of experience working with clinical trials in a data management-related role, or equivalent combination of education and experience
o Knowledge of Clinical Trial processes, specifically as they related to data collection, management, and preparation for statistical analysis
o Strong understanding of data management plans/customer specifications for data entry screens, edit checks, custom reports and data integrations
o Ability to work with technical R&D staff and translate new software features into real world examples
o Knowledge of computer usage in a web-based environment
o Ability to think logically to solve complex problems
o Excellent verbal and written communication skills, organizational and time management skills
o Solid analytical and technical skills with regard to software applications
o Experience supporting project teams and meeting project timelines
o Strong collaboration and team-building skills
o Self-motivating, able to assume responsibility and work autonomously in a professional manner

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