Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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. • 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. Qualifications • 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. Requirements • Compensation DOE - $190k - $220k salary + bonus, equity and supporting package Apply tot his job