Clinical Data Manager

About the company

Azurity Pharmaceuticals is a privately held specialty pharmaceutical organization focused on creating innovative medicines for patients whose needs are often underserved. The company combines its internal strengths with a wide partner ecosystem to grow a diverse commercial portfolio and a strong late-stage pipeline. Its patient-focused therapies serve areas such as cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan care, and have supported millions of patients.

Azurity Pharmaceuticals promotes an inclusive workplace and follows equal opportunity hiring practices. The organization values people who bring strong motivation, integrity, and creative thinking, and who are committed to improving patient lives through high-quality science and execution.

Role overview

The Clinical Data Manager will own data management operations and coordinate all data-related activities for assigned studies and projects. The role includes supervising CRO-led database setup, carrying out user acceptance testing, reviewing study documents, and ensuring data quality and integrity from study initiation through database lock.

Key responsibilities

• Drive and coordinate complete data management activities for outsourced clinical trials across Phases 1 to 4.
• Review and monitor the creation of Data Management Plans, CRFs, edit check specifications, and related essential study documents prepared by CRO partners.
• Oversee database construction, including checking database specifications, edit checks, and UAT execution in EDC platforms.
• Work with systems such as Medidata Rave, Oracle InForm, or comparable EDC tools.
• Maintain strong data quality by ensuring timely collection, cleaning, reconciliation, and database closure activities.
• Partner with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and external vendors/CROs to keep studies aligned.
• Make sure all data handling meets GCP, FDA, and other relevant regulatory requirements.
• Contribute to protocol development, CRF design, query handling, and data cleaning to support interim and final analyses.
• Manage and review data reconciliation, external data transfers such as lab and imaging feeds, and coding support including MedDRA and WHO-DD.
• Maintain complete and inspection-ready data management documentation in TMF section 10.

Required experience and qualifications

• Bachelor’s or Master’s degree in Life Sciences, Data Science, Computer Science, or a closely related discipline.
• At least 8 years of experience in clinical data management.
• Solid knowledge of EDC systems and clinical data standards such as SDTM and CDISC.
• Hands-on experience with database setup during study start-up and database lock during study closeout.

Preferred background

• Ability to lead multiple projects at the same time.
• Experience creating multiple eCRF designs.

Eligibility and declaration

Applicants must be mentally and physically able to perform all responsibilities described for this role. If you have any concern, including even a minor disability that could affect job performance, you are expected to inform HR in advance.