Help create a healthier world. Start right here at IQVIA. Enter Location Principal Technical Designer/Clinical Data Manager Locations: Wilmington, NC ; Durham, NC ; San Diego, CA ; Boston, MA ; Plymouth Meeting, PA ; Overland Park, KS Full time R1146219 Date Posted: 09/22/2020 Job Title: Clinical Data Manager Business Title: Principal Technical Designer Responsibilities : Reviews and interprets the study protocol and updates provided by the DTL Designs and updates the eCRF for builds Provides input regarding the eCRF updates to the ALS/eCRF Creates and updates the Edit Specifications document With minimal guidance, serve as back-up for other Technical Designers, providing leadership and technical expertise for study build/post-production work Attends any Kick-off Meeting, Pre-Design Meeting, Online Screen Review Meeting or other meeting related to the study build/post-production work Communicates any project risks to the DTL, including any risk for missing a timeline in the Data Management Project Plan Identifies and escalates potential Quality Issues Ensures the completion and documentation of all project-specific training, as well as staying current with required SOP reading Reviews build/post-production project plans and provides inputs Reviews QIP for project activities, identifies out of scope activities if any and informs relevant parties Coordinates activities and responsibilities for study builds and post-production work which may span multiple sponsors at the same time across multiple platforms Develop and maintain good communications and working relationships with CDM team. Interact with CDM team members to negotiate timelines and responsibilities. Identify areas for process improvements continuously. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions/ideas for continuous improvement of the process. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Expert in interpreting the protocol and map information in the clinical protocol into eCRFs Extremely confident to answer questions related to eCRF design/analysis and discuss suggestions provided by other teams. Strong understanding of the purpose and content of Edit specifications/ DVS and able to independently create a complete Edit specs/DVS document and support other TDs as required. Confident to answer questions related to Edit specs and provide strong reasoning to back responses. Excellent technical knowledge of technical tools and processes (e.g. Central Designer, ALS, Rave, etc.) and protocol interpretation skills. Complete understanding of the database and capable of handling questions from the sponsor and internal team and provide solutions. End to end knowledge of data management processes in order to understand the impact of database set-up on the conduct phase. Complete knowledge of project timeline components related to TD activities and relation to programming and testing activities and capable of providing comments on the timelines. Knowledge in 3-4 therapeutic areas. Experience in library creation and maintenance. Expert knowledge of TD activities in at least 2 different platforms Subject Matter Expert in study design related aspects At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com . IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [email protected]
to arrange for such an accommodation.