The Manager, Clinical Study Management is responsible for managing operational execution and study management components for clinical studies. Ensures protocol and regulatory compliance, as well as significant interaction.

• Responsible for staff management in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning assigning and directing work; addressing complains and resolving problems; development and coaching employees. 
• Plan, organize and facilitate workloads and schedules of staff to ensure that timelines are met and to ensure appropriate CSM coverage. 
• Attend and participate in study specific meetings related to study set up, timeline and production of management, study status and data cleaning. 
• Oversee data QC and DM functions required for on-time performance and compliance with regulatory and internal procedural requirements. May be required to carry out study tasks to support team workload. 
• Participate in standard monitoring visits, site qualifications, regulatory inspections and sponsor audits as required. 
• Monitor process efficiency and implement process improvement as needed, including identification of error trends and resolutions. Lead and/or participate in problem-solving for the clinical processes. Lead and/or participate in functions required to ensure success of the clinical operations. 

• Bachelor’s degree in a related field required
• 1-2 years supervisory experience preferred
• Prior Clinical Study Manager experience preferred
• Ability to organize and manage multiple priorities required
• Excellent oral and written communication skills required
• Problem solving skills required
• Knowledge of Good Clinical Practices, Medical Terminology, ICH Guidelines and 21 CFR Part 11 preferred