Clinical Trial Manager Ii - (US-CA-South San Francisco - 94083)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Summary of : The Clinical Trial Manager II is accountable for the day-to-day operations of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities. Job Duties/: • Performs job duties with minimal guidance from the Clinical Program Manager. • Leads the Protocol Execution Team (PET) to ensure that trial timelines, costs, and quality metrics are met • Serves as primary contact for functional area representatives in managing protocol execution • Ensures accuracy and timeliness of vendor and site payments • Oversees forecasting of clinical/non-clinical supplies • Establishes study milestones and ensures accurate tracking and reporting of study metrics • Manages trial-specific Genentech collaborations with other research entities (e.g., Cooperative Group Trials, Investigator Sponsored Trials, Global Partner Trials) • Performs ongoing vendor management (e.g., CROs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution • Creates and manages clinical trial budgets and staffing/resourcing plans • Provides study-specific direction and mentoring to Clinical Site Managers, Clinical Trial Associates and support staff as appropriate • Provides support and mentoring to other Clinical Trial Managers • Ensures trial adherence to ICH/GCP/local regulations • Participates in clinical operations initiatives and programs as assigned Competencies Identified for Success: • Highly developed leadership to build and direct the Protocol Execution Team to ensure that timeline, cost and quality metrics are met • Effective written and verbal communication • Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology • Collaborates effectively with the Clinical Operations study team, cross-functional team members, and external partners Education, Experience, and Other

Requirements : • Bachelor’s Degree with a minimum of five years of clinical research experience • Therapeutic knowledge preferred • Knowledge of GCP and ICH • Proficient computer .

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