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Skills & Qualifications:
Required Qualifications:
• Bachelor’s Degree
• Minimum of five years of related experience, ideally in a clinical research environment and/or in clinical study management.
• Understanding of GCP and 21 CFR 812
Preferred Qualifications:
• Experience with building clinical databases and data analysis
• Minimum of ten years of related experience, ideally in a clinical research environment
• Experience with US and international based clinical studies
Experience Level:
Expert Level
Description:
Responsibilities:.
• Responsible for managing clinical studies in accordance with internal standard operating
procedures and applicable regulations and guidelines
• Strategically plan, sequency, and scope clinical studies to build clinical evidence to support
therapy adoption
• Collaborate with internal and external clinical team members, consultants, and/or CROs to
draft clinical study protocols, Instructions for Use, Report of Prior Investigations,
Investigational Brochures and other clinical study documentation
• Oversee clinical site selection and activation
• Manage study safety by tracking and reporting adverse events as required by regulatory
bodies, reviewing adverse event trends, and overseeing safety committees including Clinical
Events Committees and Data Safety Monitoring Boards
• Oversee monitoring activities related to assigned clinical studies including review and
approval of monitoring plan and monitoring reports, managing monitoring schedule and
ensuring corrective action related to monitoring findings
• Develop training plans for study training and review/approve training documentation
• Prepare study-related reports including annual, interim and final study reports
• Organize and lead study-related conference calls and Investigator meetings as needed
throughout the study
• Oversee investigational device allocation, distribution and reconciliation
• Collaborate with data management team to ensure appropriate data capture and query
management
• Assist with and/or perform data analysis
• Ensure proper closeout and archiving of data management study related materials, i.e.
database change documentation, validation documents, and final patient casebooks in paper
or electronic format;
• Build effective working relationships with team members
• Document product and therapy related field reports within the prescribed timelines and
provide any necessary documents required to complete the investigation. Provide follow-up
reporting as needed.
• Complete training requirements and competency confirmations as required for this position
within the required timeline.
• Comply with applicable quality system procedures/policies and make suggestions for
continuous process improvement
Skills:
Clinical research, Clinical trial management, Clinical project management, Medical device, Budget management, CRO, Vendor management
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Full Time
$88k-115k (estimate)
05/18/2024
05/29/2024
The job skills required for Clinical Study Manager include Clinical Research, Initiative, Project Management, Data Management, Process Improvement, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Study Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Study Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Study Manager positions, which can be used as a reference in future career path planning. As a Clinical Study Manager, it can be promoted into senior positions as a Clinical Research Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Study Manager. You can explore the career advancement for a Clinical Study Manager below and select your interested title to get hiring information.