Join to apply for the Senior Clinical Data Manager role at Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the Senior Clinical Data Manager role at Katalyst CRO Get AI-powered advice on this job and more exclusive features. Maintain all Data Management project documentation in an audit-ready manner. Provide day-to-day support to Clinical Study Teams to ensure data is reviewed and discrepancies are resolved. Oversee Data Management activities from study start-up to close-out. Develop and manage study timelines and ensure the quality and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders). Author key documents, including Data Management Plans, Data Review Guidelines, eCRF Completion Guidelines, and study timelines. Prepare training materials for Investigator Meetings, internal teams, and site staff. Support Lead Clinical Programmers in developing and managing Data Transfer Agreements. Lead regular data review across studies, identifying quality issues, trends, and outliers, and generate queries as needed. Reconcile data from external sources. Assist in creating CRF and Edit Check Specifications. User Acceptance Testing (UAT) of clinical databases, including EDC systems. Manage EDC User Access for all assigned studies. Collaborate with internal stakeholders to meet study timelines and deliverables. Work with Clinical Programming to produce reports for efficient data review and cleaning. Facilitate cross-functional Data Management meetings with Study Managers, Project Managers, Programming, and Regulatory teams. Review study protocols and provide feedback on data collection methods. Contribute to the development and improvement of departmental processes. Participate in updating Data Management standard operating procedures, work instructions, and templates. Responsibilities Maintain all Data Management project documentation in an audit-ready manner. Provide day-to-day support to Clinical Study Teams to ensure data is reviewed and discrepancies are resolved. Oversee Data Management activities from study start-up to close-out. Develop and manage study timelines and ensure the quality and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders). Author key documents, including Data Management Plans, Data Review Guidelines, eCRF Completion Guidelines, and study timelines. Prepare training materials for Investigator Meetings, internal teams, and site staff. Support Lead Clinical Programmers in developing and managing Data Transfer Agreements. Lead regular data review across studies, identifying quality issues, trends, and outliers, and generate queries as needed. Reconcile data from external sources. Assist in creating CRF and Edit Check Specifications. User Acceptance Testing (UAT) of clinical databases, including EDC systems. Manage EDC User Access for all assigned studies. Collaborate with internal stakeholders to meet study timelines and deliverables. Work with Clinical Programming to produce reports for efficient data review and cleaning. Facilitate cross-functional Data Management meetings with Study Managers, Project Managers, Programming, and Regulatory teams. Review study protocols and provide feedback on data collection methods. Contribute to the development and improvement of departmental processes. Participate in updating Data Management standard operating procedures, work instructions, and templates. Requirements Bachelor's degree or higher in biological science, nursing, or a related health field preferred. Minimum of 6 years of experience in clinical data management, preferably within the pharmaceutical or medical device industry. Strong understanding of clinical trial processes, FDA/ICH guidelines, and Good Clinical Data Management Practices (GCDMP). Hands-on experience with Electronic Data Capture (EDC) systems such as MedNet, Rave, and Veeva Vault EDC. Proficiency in data review and use of reporting/analytics tools. Excellent project management and documentation skills, with experience writing Data Management Plans, Data Review Guidelines, and study timelines. Strong verbal and written communication skills. Ability to manage multiple clinical studies and tasks simultaneously. Knowledge of CDISC Standards (CDASH, SDTM). Problem-solving skills and flexibility in responding to business needs. 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 Get notified about new Senior Clinical Data Manager jobs in Danbury, CT . AI & Data Manager - Life Sciences R&D Clinical (Pharma) Stamford, CT $130,800.00-$241,000.00 2 weeks ago 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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