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Alpha-9 Oncology, a clinical-stage biotech company developing radiopharmaceutical therapies for solid tumors, is seeking a Clinical Operations Manager to support the day-to-day execution of oncology clinical trials. You will report to the Clinical Operations Leader and serve as a hands-on coordinator ensuring clinical activities align with protocols, regulations, and company SOPs.
Key responsibilities include: tracking clinical trial timelines, budgets, operational metrics, and study risks (site activation, enrollment, monitoring); supporting CRO/vendor selection strategy and country/site selection; managing day-to-day vendor relationships including contract tracking, budgets, invoices, and scope-of-work alignment; contributing to protocol development, informed consent forms, study manuals, eCRF, and regulatory documents; collaborating with Data Management, Clinical Sciences, and Clinical Development teams; reviewing site monitoring reports; maintaining Trial Master Files (TMF) and ensuring CRO TMF completeness; forecasting and managing clinical trial supplies; assisting with Investigator and Study Coordinator meetings; and ensuring regulatory compliance with ICH, FDA, EMA guidelines and company SOPs.
You will be a problem-solver who thrives in fast-paced environments, coordinating across internal teams and external vendors to translate study strategy into effective execution. The role requires strong organizational skills, attention to detail, excellent written and verbal communication, and the ability to work independently while escalating issues appropriately. You should be proactive in identifying and resolving operational challenges and comfortable rolling up your sleeves to get work done.
