ClinicalDataManager

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. About the Role The Clinical Data Manager is responsible for data management operations and for the organization, coordination and execution of data management activities for assigned studies and projects. This includes but is not limited to oversight of CROs conducting database set-up (e.g., perform user acceptance testing), review of study documents, and data review to ensure data integrity from study start-up to database lock. Key Responsibilities Lead, manage, execute end-to-end data management activities for clinical trials (Phase 1 to 4) outsourced to CROs. Review and oversee development of Data Management Plans (DMPs), CRFs, edit check specifications, and other essential documents by CROs. Oversee database build-up including validation of the DB specs, edit checks, and UAT processes in EDC systems Expertise with Medidata Rave, Oracle InForm, or similar EDC systems. Ensure timely and high-quality data collectio