Job Description The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate, consistent, and meets regulatory and protocol‑specific requirements. This role collaborates closely with cross‑functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution. Responsibilities Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol. Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines. Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams. Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations. Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH‑GCP). Manage database lock activities and contribute to the preparation of clinical study reports (CSRs). Serve as the primary point of contact for data management vendors and oversee their deliverables. Participate in study team meetings and provide status updates related to data quality and timelines. Support audit readiness and participate in regulatory inspections when required. Requirements Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field. Advanced degree is a plus. Minimum of 35 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment. Proficiency in EDC platforms (e.g., Medidata Rave, Oracle Inform, Veeva, Redcap). Strong understanding of ICH‑GCP, FDA regulations, and CDISC standards. Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHO Drug). Excellent organizational, analytical, and problem‑solving skills. Strong communication and collaboration skills across cross‑functional teams. Experience working on global, multi‑site clinical trials preferred. Seniority level: Associate Employment type: Contract Job function: Information Technology Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO
...Great Life work Balance position with excellent benefits! The Interpreter provides language interpretation services between limited... ...participants in social and informational settings. Maintain proper medical terminology vocabulary and fluency both in English and target...
...Overview Shaw Commercial is a global design leader in commercial flooring for some of the worlds most creative and innovative... ...awareness for our commercial flooring brands, Patcraft and Shaw Contract. Our ideal candidates home office location is in San Francisco,...
Synergisticit Job Opportunity Since 2010 SynergisticIT has helped job seekers get employed in the tech job market by providing candidates the requisite skills, experience, and technical competence to outperform at interviews and at clients. Post Covid the tech layoffs...
...Position The Video Editor & Producer for Sporting Kansas City is a key contributor within the Creative and Brand Team, responsible for... ...experiential activations Occasional away gameday travel or remote gameday work will be required. Personal Attributes ...
...: Piramal Pharma Solutions HPAPI Research and Manufacturing facility located in Riverview, Michigan, is seeking a qualified Chemical Operator II to join our Production team. The Chemical Operator II is responsible for conducting chemical syntheses/manufacture of active...