Techinical Designer II - Medidata RAVE at Labcorp Drug Development

Summary of Opportunity

• Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE.
• Responsible for designing the eCRF in RAVE.
• Responsible for the preparation and /or review draft and final eCRF, edit check specifications for assigned projects to ensure quality and consistency.
• Specification development for study build and design of EDC database.
• Follow attention to detail approach and participate in sponsor meetings and audits/inspections.
• Liaise with data managers to discuss technical strategies, contract obligations and timelines.
• Responsible for performing quality control procedures for specification development.
• Conducts team meetings and provide guidance to Programmers and Data managers.
• Responsible for maintaining study specifications for assigned projects.
• Responsible for conducting Quality Control of study design for assigned projects.
• Participate in the validation of EDC studies when requested.
• Responsible for the creation and maintenance of library objects within the Global Libraries.
• Responsible for the review and approval of deviations and edit checks requested by the project teams.
• Mentor and aide in staff development, and achievement of competency standards.
• Present training programs to the technical staff regarding study build, standards maintenance, and/or change control.
• Notify project leadership of requests for out-of-scope work and advise management of changes in scope of projects to enable the timely development of change orders.
• Provide consultation in the area of database design and development with data managers.
• Maintain awareness of new developments in EDC vendor products which may be applied to
  improve the efficient use of these systems.
• Implement processes as they are refined, or as new processes are developed and initiate and
  participate in the ongoing review of the processes to ensure they are continually improved.

Experience

• Good knowledge of drug development process and Clinical Data Management Programming.
• End to end Medidata RAVE build experience.
• Technical expertise: Design Screens & Program Edits in RAVE.
• Some experience dealing with amendments and assessing risk associated with them.
• Good oral and written communication skills.
• Ability to work in a team environment.
• Ability to work effectively under minimal supervision.
• Good time management skills and the ability to work to tight deadlines whilst maintain the highest standards of quality work.
• Candidates must be fluent in English language (both verbal and written).