Clinical Study Manager
3 weeks ago
**Location: Remote, Canada**:
**Resuscitation**:
ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.
We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL
**Job **Summary**:
The Clinical Study Manager is responsible for all aspects of clinical study management for one or more clinical studies and provides expert advice and guidance to allocated project activities; may be responsible for direct management of clinical employees. The position contributes to the Clinical Research team activities for designated projects and ensures patient safety, quality and integrity of data, compliance with relevant SOPs and regulatory requirements, and completes studies on-time and on-budget.
**Essential **Functions**:
- Responsible for writing and development of the protocol, informed consent, and other study
- specific documents
- Responsible for the clinical project plan; including overall study budget
- Manages development of the clinical site training materials; responsible for planning the investigator meetings
- Responsible for the design, development, and testing of the CRFs and databases in collaboration with the study data manager
- Build and maintain solid professional relationships with key opinion leaders and clinical study site staff
- Responsible for determining contract services needs and site and vendor contract negotiation in collaboration with legal departments, assists with vendor selection
- Manages the establishment of the Clinical Trial Master File and ensures proper document control
- Responsible for collection, filing, and tracking of site regulatory documents
- Manages site regulatory submission and approval process; responsible for country regulatory submission in collaboration with Regulatory Affairs and approval internally or with vendor
- Responsible for negotiation of site contracts and budgets; responsible for study budgets and accruals; clinical site training; study data, and database function in collaboration with the study data manager
- Responsible for site monitoring; conducts on-site monitoring and study closeout visits, writes reports and site correspondence, co-monitors (trains and evaluates) other ZOLL CRA's
- Responsible for clinical data and regulatory reports in collaboration with Regulatory Affairs, and timely management of study publications; may present data at scientific meetings
- Responsible for periodic audits of clinical study files for completeness
- Communicate with the cross-functional study team, the management team, and clinical vendors as required, concerning status and progress of the trial
- Contributes to departmental regular meetings for project update and review
- Contributes to ongoing SOP review and development
**Skills **Requirements**:
- Advanced oral and written communication skills
- High attention to detail and accuracy
- Proficient knowledge of medical terminology
- Expertise with GCPs and regulatory and compliance guidelines for clinical trials
- Advanced problem-solving skills
- Requires up to 75% travel
**Required/Preferred Education and **Experience**:
- Bachelor’s degree in a health sciences; preference for degrees in biological sciences, engineering, or related medical/scientific field
- 5-10 years of experience directly supporting clinical research or similar experience in a medical/scientific area
LI-JP1
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