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Clinical Data Monitor Globus Medical
DescriptionClinical Data Monitor
The position is responsible for performing monitoring activities associated with all ongoing Class III FDA-related clinical studies. This individual will need to perform site monitoring visits by adhering to the schedule established in Globus SOPs to ensure the investigational sites are conducting the study according to the approved protocol and all applicable regulatory requirements. This person must be enthusiastic, positive, even-tempered and effective in building working relationships with various external consultants, clinical site personnel, and Globus Clinical Affairs and Regulatory staff. This individual must adhere to FDA 21 CFR regulations in all duties and must be able to travel up to 85 of the time to destinations across the United States.
Primary Responsibilities
Schedule and perform monitoring visits for all clinical trials in accordance with established Globus SOPs
Perform thorough review of study-related information and files at each site visit (compliance with approved protocol, proper informed consent, compliance with inclusion/exclusion criteria, etc.)
Help ensure proper documentation for and reporting of adverse events
Document all findings for monitoring visits, maintain and update issue tracking log, write and distribute Monitoring Reports
Work closely with clinical site personnel and members of the Globus Clinical Affairs department to ensure timely resolution to identified issues
Promptly notify Globus Clinical management of any site negligence, non-compliance or severe protocol deviations
Review clinical data for trends in missing or incorrect data relating to sites or investigators
Assist with other tasks as assigned by the Clinical Affairs Group Manager
Review, improve and train staff on relevant Clinical Affairs SOPs as needed
Qualifications:
Experience performing clinical monitoring for IDE studies or studies involving medical devices (spinal device experience preferred)
Must be detail-oriented
Excellent verbal, written and organizational skills
Ability to work effectively in a fast-paced, team-oriented environment
Good computer skills
BS degree in health science or related field.
| Location: | Valley Forge Business Center 2560 General Armistead Avenue Audubon, PA 19403 United States |
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Globus Medical
Investors: Clarus VenturesAll Jobs: at Globus Medical
| Web Site: | www.globusmedical.com |
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| Headquarters: | Valley Forge Business Center 2560 General Armistead Avenue Audubon, PA 19403 United States |
| Industry: | Medical Devices and Equipment |
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