Clinical Project Analyst
Clinical Services Department / Operations Division

Medidata Clinical Project Analysts help ensure that eCDM applications are developed in accordance with Medidata standard business processes, meet client requirements and adhere to Good Clinical Data Management Practices. Clinical Project Analysts work with eCDM Specialists, Project Managers and other functional departments during the development of eCDM 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 Clinical Project Analyst will be the primary resource for the authoring of specification documents used by different groups during the configuration of clinical studies using Medidata’s RAVE eCDM product.

Skills:
• Knowledge of Clinical Trial processes, specifically as they related to data collection, management, and preparation for statistical analysis
• Ability to understand 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 for the eCDM team.
• Knowledge of Computer usage in a web-based environment
• Ability to think logically to solve complex problems
• Excellent verbal and written communication skills
• Solid analytical and technical skills
• Experience supporting project teams and meeting project timelines
• Excellent organizational and time management skills
• Strong collaboration and team building skills.
• Self-motivating, able to assume responsibility and work autonomously in a professional manner.

Qualifications:
• 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

Responsibilities:
• 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 clinical 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)
• Review edit check requests/requirements from clients and determine whether complex or simple
• Author complex edit check specification including test scripts
• Review requests for complex edit checks received from shared study build clients to ensure that cannot be completed with simple checks
• Coordinate and support eCDM Specialists and DIG programmers during edit checks development
• Author custom report specifications based upon client requirements, including functional test cases
• Support Reporting Specialists during custom reports development regarding required functionality
• Assist Outputs Specialists during output configuration
• Support and mentor Project Managers who are new to clinical trials on studies
• 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
• Advise customers and internal Medidata staff such as eCDM Specialists on best practice for clinical database setup, data structures, entry screen layout, edit check configuration, local labs
• Support data integrations on studies with Project Management/DIG on data transfer plan creation to ensure data integrations meet customer requirements
• Work with IT/DIG and vendors such as central labs to ensure that all back-end clinical data changes follow best clinical data management practices
• Provide hands on study configuration support (e.g., eCRF development, simple edit check creation) to supplement eCDM Specialists
• Work with other eCDM specialists and project managers in the EDC configuration process
• Work with QC for all EDC application projects
• Author meeting minutes
• Provide written regular status reports