Role Summary

A clinical-stage oncology biotech is looking to bring on a Senior Manager or Associate Director of Clinical Data Management to support a high-impact Phase III study and help drive data quality across the development portfolio.

Responsibilities:

• Oversee study-level data management activities in collaboration with CROs, vendors, and internal teams.
• Own and execute internal data review activities, including development of data review plans and audit strategies.
• Lead user acceptance testing (UAT) efforts for clinical systems (EDC, eCOA), ensuring systems are fit-for-purpose and compliant with internal best practices.
• Support the design and validation of CRFs, edit checks, and data transfer specs for external data (e.g., labs, ECGs, PK).
• Contribute to study documentation and quality oversight by reviewing metrics, trending issues, and identifying opportunities for process improvement.
• Review and contribute to SOP development and ensure inspection readiness across data systems and documentation.
• Act as internal study data lead where required, ensuring CRO deliverables are on-time and meet defined quality standards.

Requirements:

• Bachelor’s degree in Life Sciences, Health Informatics, or a related discipline.
• 5+ years of experience in clinical data management within biotech/pharma.
• Strong working knowledge of EDC platforms (e.g., Rave, Oracle Clinical) and CDM processes.
• Oncology experience required; pivotal trial experience preferred.
• Excellent communication skills and ability to work cross-functionally in a fast-paced setting.
• Highly organized, detail-oriented, and confident owning timelines and deliverables.

Compensation DOE - $190k - $220k salary + bonus, equity and supporting package