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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.
Role Description This is a high-impact, hands-on programming position operating at Associate Director level, working closely with senior leadership to support critical business needs. Key Responsibilities - Act as a key internal technical resource across statistical programming activities - Deliver high-quality dashboards and visualizations using SAS, R Shiny and/or Python - Partner directly with executive leadership (C-suite) to support internal reporting needs - Respond to ad hoc requests from health authorities - Contribute to a growing Biometrics function within a small biotech environment Qualifications - Strong hands-on experience with SAS in clinical trials - Experience using R and/or Python - Proven ability to deliver high-quality outputs in a fast-paced environment - Experience supporting ad hoc regulatory requests - Background within a sponsor, CRO or academic setting - Ability to work independently while engaging with senior stakeholders