Description
An exciting mid sized pharmaceutical company located inSouth San Francisco is looking for an experienced Clinical Project Manager to join their team!The Clinical Project Manager will be responsible for managing the day-to-day operations of 1-4 clinical trials, including trial start-up, interim, and closeout activities. This person will manage the overall operation of the entire clinical study including project planning, budget, resource management and contract research organization management. This candidate will oversee the clinical trials staff and manage all aspects of clinical operational plan. The will be responsible for managing the full scope of study, protocol and scientific publications, and will act as a cross functional liaison to ensure study plan aligns with business development strategies.
DUTIES AND JOB RESPONSIBILITIES:
· Serve as primary contact for all internal and external parties in managing protocol execution.
· Perform ongoing vendor management, including negotiation of scope of work, budgets, performance management, and issue resolution.
· Ensure that trial timelines, costs, and quality metrics are met. Establishes study milestones and ensures accurate tracking and reporting of study metrics
· Create and manage clinical trial budgets and staffing/resourcing plans
· Oversee forecasting of clinical/non-clinical supplies
· Ensure accuracy and timeliness of vendor and site payments.
· Provide study-specific direction to CRO, Clinical Coordinator and support staff as appropriate
· Ensure trial adherence to ICH/GCP/local regulations.
· Participate in clinical operations
· Bachelor's Degree in Life Sciences.
· 3-5 years industry experience in drug development of clinical research experience
· Oncology experience preferred
· Knowledge of GCP and ICH
· Develops realistic trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
· Effective in a variety of formal presentation settings, one on one, small and large groups. Writing skills are proficient.
· Solves difficult problems with effective solutions, can see underlying or hidden problems or patterns and proactively presents of implement correction actions.
· Collaborates effectively with study teams, cross-functional team members, and external partners
· Proficient computer skills
To find out more about Real please visit www.realstaffing.com