Manager, Clinical Study Management
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Job Description
Manager, Clinical Study Management leading clinical studies for medical device testing compliance. Ensuring regulatory standards and collaborating with teams throughout the project lifecycle.
Responsibilities:
- Leading clinical study management activities for medical device testing
- Ensuring adherence to regulatory standards and timelines
- Collaborating with cross-functional teams to deliver project goals
- Coordinating site operations from initiation to close-out
Requirements:
- Bachelor’s degree or equivalent experience in a related field, with a minimum of 5 years of relevant experience including 2 years of management experience
- Knowledge of Good Clinical Practices and other regulations which apply to medical device trials at various stages of development (feasibility, pivotal, post-market) and ability to adapt trial oversight accordingly
- Familiarity with all aspects of the clinical trial process including, but not limited to protocol development, site selection/qualification, site initiation, monitoring, close-out, investigator meetings, DSMB/CEC, core lab management, and site compliance escalation
- Multidiscipline (at least 2 specialties) therapeutic knowledge
- Familiarity with medical device development process from pre-clinical to commercialization
- Understanding of the role of data management and biostatistics in the clinical trial process
- Understanding of the type and quality of data needed from a clinical trial and how it should be presented
- Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC personnel, and clients (and persuade them to do what is needed)
- Ability to participate in and present during an FDA/notified body/regulatory inspection
- Strong management and strategic business mindset and skills
- Ability to provide work direction, to include organizing, prioritizing, negotiating, communicating relevant project information and scheduling work assignments
- Ability to handle multiple priorities and issues, foster a cooperative work environment with high quality standards, and facilitate and manage effective meetings.
Benefits:
- Best-in-class customer experiences
- Professional development opportunities
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