Clinical Trial Manager III

Delta, a leader in the clinical research staffing and functional service arenas.

Clinical Trial Manager III
The Clinical Trial Manager III 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/Responsibilities:
• Performs job duties independently 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 vendors scope of works and 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 skills to build and directs the Protocol Execution Team to ensure that timeline, cost and quality metrics are met
• Effective written and verbal communication skills
• Extensive 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 eight years of clinical research experience
• Therapeutic knowledge preferred
• Knowledge of GCP and ICH
• Proficient computer skills
• Travel may be required


EOE
REQUIREMENTS
This is a permanent position in South San Francisco. We have multiple openings.
Relocation packages are available.

Please call Jay VanHousen/847-317-9544, ext.245
E-Mail: [Click here for email]