Job Title: Assistant Director, Clinical Trials Operations ResponsibilitiesLeads and manages the clinical trial operations for an oncology disease group. Develops strategies and specific goals for the assigned portfolio, and creates budgets, policies, and procedures to support the operational framework.Provides strategic guidance to leadership for both short-term and long-term planning for the Clinical Trials Office. Establishes and implements objectives for the assigned portfolio focusing on productivity, compliance, communication, and patient satisfaction.Develops and executes process improvement initiatives to achieve set goals and objectives.Oversees the recruitment, hiring, career development, performance evaluations, disciplinary actions, and daily supervision of clinical research professionals (including clinical research managers, clinical trials project managers, data coordinators, clinical research coordinators, and clinical research nurses).Sets priorities with appropriate timelines to ensure efficient and effective operations. Allocates resources among teams in collaboration with faculty oncology disease group leaders.Collaborates with the Quality and Education unit to ensure proper training and education of clinical research professionals (data coordinators, clinical research coordinators, clinical research nurses, and clinical research managers) regarding clinical responsibilities. Together with the Quality and Education unit, develops, implements, and updates oncology-specific role-based training programs for new employees.Ensures full compliance of clinical research operations within the scope of the position. Prepares responses to audit findings and designs, implements, and monitors corrective action plans.Implements operational changes to achieve top-tier operations throughout the organization based on internal or external audit findings, ensuring full compliance with the Clinical Trials Reporting Program (CTRP) requirements. Manages and directs the data management functions related to oncology clinical research for assigned disease team portfolios, including effective collaboration with external sponsors on data collection platforms.Oversees the processes necessary for the effective and timely activation of clinical trials within the disease team portfolio, from protocol concept to open-to-accrual status. Uses data to monitor the protocol activation process effectively. Qualifications10+ years clinical operations experience 2+ years supervisory experienceWill have 5 direct reports and oversee 40 staff Study management experience Bachelors degree Work Environment
Hybrid work environment with onsite presence required twice a week.
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