Join to apply for the Clinical Data Manager role at Katalyst CRO 2 days ago Be among the first 25 applicants Responsibilities Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level. Oversee data cleaning, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions. Collaborate with external data management vendors to ensure timely and high-quality deliverables, tracking performance against project timelines and quality standards. Participate in the preparation, review, and validation of submission‑ready datasets for regulatory filings (e.g., NDA, BLA, MAA). Ensure compliance with industry standards and regulations (GCP, FDA, EMA) and assist in audit and inspection readiness. Coordinate with internal stakeholders including Clinical Operations, Biostatistics, Regulatory Affairs, and IT to ensure smooth data integration and reporting. Contribute to the implementation and optimization of clinical data systems and tools (e.g., EDC, data review platforms). Requirements Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field. 7+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry. Experience managing study‑level data management activities and working with external vendors. Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM). Demonstrated experience supporting regulatory submissions is a plus. Strong problem‑solving, organizational, and communication skills. Seniority level Mid‑Senior level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO
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