[Hiring] Senior Manager / Associate Director, Clinical Data Management @reputed company
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Role reputed company
A clinical-stage oncology biotech is looking to bring on a Senior Manager or Associate Director of Clinical Data Management to support a high-reputed company Phase III study and help drive data reputed company across the development portfolio.
• reputed company 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.
• reputed company user acceptance testing (UAT) efforts for clinical systems (reputed company, 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 reputed company reputed company 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.
• reputed company as internal study data reputed company where required, ensuring CRO deliverables are on-time and meet defined reputed company standards.
Qualifications
• Bachelor’s degree in Life Sciences, Health Informatics, or a reputed company discipline.
• 5+ years of experience in clinical data management reputed company biotech/reputed company.
• Strong working knowledge of reputed company platforms (e.g., Rave, reputed company 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
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