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 collection, cleaning, reconciliation, and database lock activities.
Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and external CROs/vendors.
Ensure data integrity and compliance with GCP, FDA and other applicable regulatory standards.
Participate in and contribute to protocol development, case report form design, and query management and data cleaning to support Interim and final analysis.
Conduct and oversee data reconciliation, external data integrations (labs, imaging, etc.) and support coding activities (MedDRA, WHO-DD)
Provide oversight of DM documentation within TMF section 10(DM section) to support study quality, completeness, and inspection readiness.

Required Skills And Experience

Bachelors or Masters degree in Life Sciences, Data Science, Computer Science, or a related field.
8+ years of clinical data management experience
Strong understanding of EDC systems and data standards (SDTM, CDISC).
Experience with database set-up during study start-up and locking a database at closeout

Preferred Qualifications

Proven ability to act as team lead for multiple simultaneous projects
Prior build experience with multiple eCRF designs.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.