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Job #02892

About our client Our client is a leading drug company with close to $10B in sales and over 10,000 employees worldwide. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Clinical Trial Manager San Francisco, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage day-to-day operations of 1 – 4 clinical trials (commensurate with complexity), including trial start-up, conduct and closeout activities 2) Perform job duties independently, with minimal guidance from the Clinical Program Manager 3) Lead the Protocol Execution Team (PET) to ensure that trial timelines, costs and quality metrics are met 4) Serve as primary contact for functional area representatives in managing protocol execution 5) Ensure accuracy and timeliness of vendor and site payments 6) Oversee forecasting of clinical/non-clinical supplies 7) Establish study milestones and ensure accurate tracking and reporting of study metrics 8) Manage trial-specific collaborations with other research entities (e.g. cooperative group trials, investigator sponsored trials, global partner trials, etc.) 9) Perform ongoing vendor management (e.g. CROs, IVRS, reading centers, etc.) including independent negotiation of vendor’s scope of works and budgets, performance management as well as issue resolution 10) Provide study-specific direction and mentoring to clinical site managers, clinical trial associates and support staff (as appropriate) 11) Create and manage clinical trial budgets and staffing/resourcing plans 12) Provide support and mentoring to other clinical trial managers 13) Ensure trial adherence to ICH/GCP/local regulations 14) Participate in clinical operations initiatives and programs (as assigned) Requirements 1) Bachelor's degree 2) Minimum 8 years of experience in clinical research 3) 3 years of experience in clinical trial/project management 4) Experience in developing trial plans (site monitoring strategies, risk mitigation strategies, trial budgets, site selection and clinical supplies management) 5) Good knowledge of clinical research and cross-functional understanding of clinical trial methodology 6) Knowledge of GCP and ICH guidelines 7) Ability to collaborate effectively with the Clinical Operations Study Team, cross-functional team members and external partners 8) Excellent leadership skills to build and direct the Protocol Execution Team to ensure that timeline, cost and quality metrics are met 9) Proficiency in computers 10) Superb communication skills (written and verbal) 11) Willingness to travel (as required)