Assoc Clinical Data Manager

Assoc Clinical Data Manager #clinicalresearch #clinicaltrials #medicine #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #covid #biopharma #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #pharmaceuticalindustry #phd #oncology #drugdevelopment #cra #biotechnology Job Description: Interprets the study protocol. Design and update the eCRF. Create and update Edit Specification Document. Generate specifications for EDC build components e.g., Rights and Roles, System Settings and Home Page Complete the Study Authorization Form and Trial Capacity Request Form InForm Attend the PreDesign Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. May lead Online Screen Review Meeting. Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document. Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates. Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan. Escalate potential quality issues. Ensure the completion and documentation of all projectspecific training, as well as staying current with required Standard Operating Procedures. Reviews build timelines and provide input as applicable. Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties. Responsible for multiple study design projects at the same time. Might be working on projects across multiple platforms. Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes. Requirement: Good understanding of clinical research process Excellent Communication Edit check, eCRF designing, listings, writing will be preferred. Worked on startup, post production changes or migration Any platform RaveInformOracleYDOC or any other platforms 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.