Clinical Data Associate II

The Clinical Data Associate will contribute to the performance of Clinical Data Management activities for assigned studies according to protocols, industry standards and guidelines, and Standard Operating Procedures (SOPs). Exact title (Clinical Data Associate II or Senior Clinical Data Associate) will depend on experience and skill level.Essential Duties and Responsibilities The main responsibilities of this role include but are not limited to the following:Support Clinical Data Management activities for assigned clinical studies under the direction of the Clinical Data ManagerSupport the review, maintenance, and filing of study Data Management documentation Participate in design review of Case Report Forms (CRF) and corresponding CRF Completion Guidelines (CCG) to align with protocol requirements and data collection standardsAssist with the testing and maintenance of clinical data systems, including Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Electronic Patient-Reported Outcomes (ePRO)Perform data review activities under the guidance of the Clinical Data Manager, including execution of data checks, query review, and issues trackingPrepare data listings and metrics under the guidance of the Clinical Data ManagerAssist with data transfers and reconciliation activities in accordance with defined procedures Collaborate with cross-functional team members and external to support study activities as directedTrack activities and escalate data issues, risks, or delays to the Clinical Data Manager as appropriate Adhere to Clinical Data Management internal standards and applicable regulatory and industry requirements, including ICH guidelines, Good Practice guidelines (GxP), CDISC standards, and 21 CFR Part 11Other duties as required