Join to apply for the Clinical Data Manager role at Katalyst CRO Join to apply for the Clinical Data Manager role at Katalyst CRO Get AI-powered advice on this job and more exclusive features. Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities. Assist in creating external data transfer agreements, ensuring alignment and specifications to support data integration, analysis, and reporting. Provide support in setting up infrastructure for external data to flow into Clinical data pipelines. Assist in validation of all Data generated in clinical trials into Clinical Data pipelines. Develop and maintain working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members. Assist in preparing function for submission readiness and may support Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits. Act as a representative for Takeda in interactions with key external partners as part of the CT3 Data Acquisition team. Support timely submission and ongoing maintenance of study-related Data Acquisition documentation in TMF. Responsibilities Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities. Assist in creating external data transfer agreements, ensuring alignment and specifications to support data integration, analysis, and reporting. Provide support in setting up infrastructure for external data to flow into Clinical data pipelines. Assist in validation of all Data generated in clinical trials into Clinical Data pipelines. Develop and maintain working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members. Assist in preparing function for submission readiness and may support Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits. Act as a representative for Takeda in interactions with key external partners as part of the CT3 Data Acquisition team. Support timely submission and ongoing maintenance of study-related Data Acquisition documentation in TMF. Requirements: Follow procedural documents and assist in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements and include optimal processes. Escalate issues to CT3 leadership as appropriate. Develop working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles. Gain exposure to all phases of drug development. Assist in handling Clinical data acquisition and management. May support study-level negotiation and agreement for data transfer or integration. Collaborate with all levels of employees with moderate supervision required. Familiarity with FTP tools like Global cape, Clinical platforms like Veeva CDMS, Illuminate, and Veeva TMF will be beneficial. Seniority level Seniority level Associate 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. San Francisco Bay Area $160,000.00-$180,000.00 2 weeks ago Alameda, CA $86,700.00-$173,300.00 1 week ago San Francisco, CA $145,000.00-$180,000.00 2 weeks ago Associate Clinical Data Management Director Alameda, CA $160,000.00-$226,500.00 1 week ago Senior Manager, Clinical Data Management Senior Manager, Clinical Data Management Senior Manager, Clinical Data Management San Francisco, CA $190,000.00-$200,000.00 3 days ago Alameda, CA $86,700.00-$173,300.00 2 days ago Principal Data Manager - Clinical Data Quality Leader Senior Manager, Clinical Data Management Alameda County, CA $190,000.00-$225,000.00 3 weeks ago Associate Director, Clinical Programming Alameda, CA $179,500.00-$255,500.00 1 week ago Senior Director Clinical Data Management 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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