Manager, Clinical Study Management
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.
\nEssential Functions- 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
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