Join to apply for the Lead Clinical Data Manager role at Katalyst CRO 1 week ago Be among the first 25 applicants Join to apply for the Lead Clinical Data Manager role at Katalyst CRO Get AI-powered advice on this job and more exclusive features. Job Summary We are seeking an experienced Lead Clinical Data Manager to oversee and manage all aspects of clinical data management activities for multiple clinical studies. The ideal candidate will ensure the accuracy, integrity, and quality of clinical trial data while collaborating with cross-functional teams, including biostatistics, clinical operations, and regulatory affairs. Job Summary We are seeking an experienced Lead Clinical Data Manager to oversee and manage all aspects of clinical data management activities for multiple clinical studies. The ideal candidate will ensure the accuracy, integrity, and quality of clinical trial data while collaborating with cross-functional teams, including biostatistics, clinical operations, and regulatory affairs. Responsibilities Lead and manage end-to-end clinical data management activities for assigned clinical studies. Develop and maintain Data Management Plans (DMP), CRF design, and edit check specifications. Oversee the database design, validation, and UAT testing to ensure compliance with study requirements. Coordinate with CROs, vendors, and internal teams to ensure timely and high-quality data deliverables. Perform data cleaning, query resolution, and reconciliation with clinical, safety, and laboratory teams. Ensure compliance with CDISC/CDASH, GCP, ICH, and regulatory guidelines. Participate in study start-up, interim monitoring, and database lock activities. Train and mentor junior data managers and team members. Contribute to process improvement initiatives in clinical data management. Requirements Bachelor's or Master's degree in Life Sciences, Pharmacy, Computer Science, or a related field. 5+ years of experience in clinical data management, with at least 2 years in a leadership role. Experience In Oncology Required. Strong knowledge of clinical trial processes, regulatory requirements. Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault, etc.). Excellent communication, problem-solving, and leadership skills. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Biotechnology Research, Business Consulting and Services, and Hospitals and Health Care Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Clinical Data Manager jobs in Chicago, IL . Chicago, IL $83,200.00-$137,280.00 3 weeks ago Chicago, IL $60,000.00-$75,000.00 3 months ago Senior Manager Clinical Service Oncology Chicago, IL $90,000.00-$100,000.00 2 days ago Clinical Research Manager, Research Incubation Unit Rosemont, IL $185,000.00-$260,000.00 1 day ago Clinical Research Manager, Research Incubation Unit Chicago, IL $90,000.00-$130,000.00 4 months ago Chicago, IL $46,988.00-$112,200.00 1 month ago Chicago, IL $48,200.00-$48,200.00 1 month ago Chicago, IL $48,200.00-$48,200.00 1 month ago Chicago, IL $48,200.00-$48,200.00 1 month ago Nursing Quality & Regulatory Compliance Manager Chicago, IL $80,000.00-$120,000.00 4 days ago Family Support Specialist Coordinator (Center Based) Chicago, IL $60,000.00-$65,000.00 4 days ago RN Patient Care Navigator-Cross Care Continuum We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Katalyst CRO
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