Clinical Program Manager

Summary of Position:
Is accountable for the functional management of 1 -3 Clinical Trials to ensure successful protocol level execution of all clinical operations including trial start-up, conduct, and close-out activities.

Job Duties/Responsibilities:

Leads the protocol execution to ensure that trial timelines, costs, and quality metrics are met
Establishes study milestones and ensures accurate tracking and reporting of study metrics
Regularly communicates with Senior Management on the development and implementation of clinical plans
Creates and manages clinical trial budgets and staffing/resourcing plans
Ensures trial adherence to GCP/GMP and FDA regulations
Anticipates and meets internal and external customer needs and implements feedback mechanism from customers to ensure needs are met
Performs ongoing management with other involved parties including independent negotiation of scope of work, budgets, performance management, and issue resolution
Provides study-specific direction and mentoring to support staff as appropriate
Maintains clinical trial management expertise through clinical trial literature review, ongoing awareness of industry practices and participation in professional activities
Utilizes appropriate IT systems to enable successful trial execution

Competencies Identified for Success:

Effective written and verbal communication skills
Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
Collaborates effectively with the cross-functional team members, and external partners
Highly developed leadership skills to ensure that timeline, cost and quality metrics are met
Creates a positive work environment by encouraging mutual respect, innovation and accountability at all levels

Education, Experience, and Other Requirements:

Location in the San Francisco Bay Area
Minimum of 5 years clinical research experience.
Bachelor’s Degree
Imaging knowledge breast ultrasound preferred
Knowledge of GCP
Proficient computer skills
Travel will be required