Join to apply for the Clinical Data Manager role at Katalyst CRO 2 days ago Be among the first 25 applicants Join to apply for the Clinical Data Manager role at Katalyst CRO Maintain study-specific documentation, including Data Management Plans, eCRF specifications, and other related documents. Interact effectively with sponsors and oversee vendors. Develop SOPs and study-specific procedures. Manage Data Management tasks from study start-up to database lock for assigned studies. Lead multiple large and complex studies, delegating tasks as needed. Work with DB programmers to design (e)CRFs and edit checks in EDC systems. Lead User Acceptance Testing (UAT) tasks for complex studies and modules. Coordinate with Sponsor and Vendors for efficient electronic data receipt, integration, and reconciliation. Troubleshoot technical issues and design effective data review processes. Manage queries and trends to ensure data completeness and integrity. Perform coding of adverse events, medical conditions, and medications. Lead pre-lock and data lock tasks. Prepare training materials and user guides for EDC data collection tools. Provide study-specific training for team members and end users. Implement technical solutions and resolve complex issues. Provide regular status updates to cross-functional study teams, management, and sponsors. Ensure archiving of study databases and related documents. Organize and file study documentation. Provide input to cross-functional study timelines and resource requirements. Present at sales and marketing meetings for prospective clients. Assist with identification of project scope changes. Responsibilities Maintain study-specific documentation, including Data Management Plans, eCRF specifications, and other related documents. Interact effectively with sponsors and oversee vendors. Develop SOPs and study-specific procedures. Manage Data Management tasks from study start-up to database lock for assigned studies. Lead multiple large and complex studies, delegating tasks as needed. Work with DB programmers to design (e)CRFs and edit checks in EDC systems. Lead User Acceptance Testing (UAT) tasks for complex studies and modules. Coordinate with Sponsor and Vendors for efficient electronic data receipt, integration, and reconciliation. Troubleshoot technical issues and design effective data review processes. Manage queries and trends to ensure data completeness and integrity. Perform coding of adverse events, medical conditions, and medications. Lead pre-lock and data lock tasks. Prepare training materials and user guides for EDC data collection tools. Provide study-specific training for team members and end users. Implement technical solutions and resolve complex issues. Provide regular status updates to cross-functional study teams, management, and sponsors. Ensure archiving of study databases and related documents. Organize and file study documentation. Provide input to cross-functional study timelines and resource requirements. Present at sales and marketing meetings for prospective clients. Assist with identification of project scope changes. Requirements Minimum BS in a scientific or health-related field or equivalent. Minimum 9+ years of experience in Clinical Data Management. Knowledge of medical terminology and pharmaceutical notation. Expertise with EDC systems such as Medidata Rave, InForm, Medrio. Strong collaboration and leadership skills. Excellent organizational and time management skills. Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Job function Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Clinical Data Manager” roles. Medical Case Manager - Emergency Services Medical Case Manager - Emergency Services Manager, Case Management-CM Admin-FT-Days-BHMC #19312 Motion Analysis System Specialist (Full Time, Day shift) Miami, FL $90,000.00-$110,000.00 2 weeks ago Director, Facilities & Operations - School/ College/Hospital Pembroke Pines, FL $20.00-$22.00 1 day ago Director, Facilities & Operations - School/ College/Hospital (H) Advanced Practice Provider - Neurology (Full Time, Day shift) Call Center: Telecare Registered Nurse (RN) NIGHTS Registered Nurse 2 - Chemotherapy Infusion - Full Time Accounting Manager, Managed Care Finance Clinical Research Coordinator 3 - Bilingual Miami, FL $60,000.00-$70,000.00 3 months ago Senior Data Analyst (Medical beauty industry) 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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