16 Clinical Study Manager Jobs in Miami, FL
DermaSensor Inc. is Hiring a Remote Clinical Study Manager
Description
- Monitoring
- Perform monitoring visits from qualification through closeout (on-site or remote)
- Identify and qualify potential investigative sites
- Train and initiate investigative sites
- Conduct routine monitoring visits and close out visits
- Complete monitoring trip reports accurately, timely, and properly documented
- Review case report forms to ensure data compliance and accuracy
- Verify appropriate reporting and documentation of adverse events and protocol deviations per protocol requirements
- Ensure site regulatory binders are current
- Develop study-specific monitoring tools and trackers
- Maintain key study metrics to ensure milestones are met
- Study Oversight
- Manage investigative sites from study start up through close out
- Provide support to the investigator evaluation and recruitment process
- Create telephone scripts, feasibility questionnaires, and/or other related assessment tools for use in site evaluation and feasibility
- Manage the collection of initial regulatory documentation for IRB/EC submission
- Manage IRB/EC and regulatory submissions and approvals, including amendments and continuing reviews
- Assist in the preparation of study binders, manuals, or other site-specific tools
- As applicable, lead and manage contract field monitors
- Oversee Trial Master File establishment and maintenance for inspection-readiness/due diligence activities.
- Proactively evaluate and analyze site trends, evaluate study risks and mitigation strategies, and work with the cross-functional team in the review of clinical data.
- Assist in the development of study protocols, ICFs, CRFs, CRF Completion Instructions, and other study-level documents
- Provide Project Management related support as delegated
- Participate in the review and revision of departmental SOPs; provide support to establish and maintain operational infrastructure at the clinical study and departmental levels.
- Other duties as assigned
Qualifications and Experience
- Bachelor’s Degree in a health, life sciences, or other relevant field of study required
- Minimum of 3 years of field monitoring experience, preferably in medical device studies
- Experience in managing all study components (start-up to database lock)
- Thorough knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and/or country-specific regulatory environment
- Current certification through ACRP (CCRA®) or SOCRA (CCRP®)
- Experience conducting remote monitoring visits
- Experience with multiple EDC systems preferred
- Experience in start-up company environment, life sciences preferred
- Ability to travel 20-30% and flexibility to travel more based on study life cycles
- Based in or willing to relocate to South Florida (i.e., commuting distance to Miami, FL)
Job Summary
Full Time
$95k-123k (estimate)
04/05/2024
06/03/2024
dermasensor.com
Miami, WV
<25
Related Companies
The job skills required for Clinical Study Manager include Clinical Trial, Project Management, 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.
Similar Jobs
Popular Articles
