Overview Join to apply for the Clinical Data Manager role at Katalyst CRO North Chicago, IL Responsibilities Lead CDM activities for assigned clinical studies, ensuring data quality and compliance with study timelines. Design and/or support the design of clinical databases in alignment with study protocols and requirements, including creation of edit checks and dynamic functionalities. Conduct User Acceptance Testing (UAT) to validate clinical database functionality and accuracy. Author, review, and approve study-specific CDM documentation such as Data Management Plans (DMPs), Case Report Form Completion Guidelines (CCGs), Data Transfer Agreements (DTAs), and EDC specifications. Support data cleaning and validation activities to ensure completeness and accuracy of study data. Monitor study progress to ensure milestones are met and deliverables are achieved on schedule. Oversee and manage CDM vendors to ensure high-quality deliverables and adherence to project timelines. Ensure all CDM operations comply with applicable Standard Operating Procedures (SOPs) and regulatory guidelines. Identify and communicate potential risks or challenges to the Head of CDM and Clinical Project Manager (CPM) and collaborate with the study team to develop and implement risk mitigation strategies. Ensure timely and accurate filing of CDM documentation in the Trial Master File (TMF). Supervise and provide guidance to junior CDM staff on assigned studies. Perform additional CDM-related duties as required. Requirements Bachelor's degree in a health-related, scientific, or equivalent field. 58 years of experience in Clinical Data Management role. Strong understanding of Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and CDM processes. Hands-on experience with multiple Electronic Data Capture (EDC) systems. Familiarity with additional CDM tools and analytics platforms preferred. Advanced proficiency in Microsoft Excel (formulas, pivot tables); basic knowledge of SAS or other programming languages is an advantage. Proficient in Microsoft Office Suite, Microsoft Teams, and SharePoint. Excellent written and verbal communication skills. Strong organizational skills with keen attention to detail. Proven ability to prioritize, manage multiple tasks, and meet deadlines effectively. #J-18808-Ljbffr Katalyst CRO
...professional hearing, gastroenterology, podiatry, orthopedics, OB/GYN, wound care and mental health services, etc. provide out-patient or telemedicine clinics at the facility Compensation & Benefit package: Competitive base salary plus production compensation Negotiable...
...Phlebotomist at Labcorp summary: The Phlebotomist performs blood specimen collections using venipuncture and capillary techniques across all age groups while maintaining accurate patient records and providing superior customer service. They handle specimen preparation...
...Job Description Job Description Rapidly growing national tax prep firm seeking the best and brightest tax professionals.Tax season... ...for work all year round. Two years minimum experience in tax preparation, must be bilingual and have an enthusiastic personality. If...
...working every other Saturday. DaVita is seeking a Registered Nurse who is looking to give life in a hospital setting. You can make... .... Some details about this position: No Dialysis experience is required. Training may take place in a facility or a training...
...ranging from Fortune 100 to new start-up organizations. We work with job seekers in an equally broad range, from light industrial temporary workers to executive level candidates. Are you looking for a Work from Home Opportunity where you can earn up to $1280 and more per...