Salary
💰 $77,000 - $94,000 per year
About the role
- Assist and support the Lead Clinical Study Manager (operational lead) for clinical trials
- Support study planning, budget and resource management, and oversight of project vendors and subcontractors as applicable
- Manage components of projects under the direction of the Lead CSM
- Prepare and oversee distribution of study documents and materials including data collection forms, manuals of operations and technical memos to research sites
- Assemble and distribute study supplies and data collection forms to clinical sites
- Coordinate and schedule conference calls; write and distribute meeting minutes
- Manage correspondence and project communications
- Prepare and update progress reports and client/study/network meeting materials
- Assist with preparation of site or investigator training materials and participate in trainings for clinical study staff
- Collaborate with data management team to develop and implement data collection and management strategies
- Participate in quality control activities
- Monitor risks and implement mitigation strategies
- Gather background data and information to support proposal and project efforts
Requirements
- Bachelor's Degree and 3 years of experience, Master's degree and 1 years of experience, or equivalent combination of education and experience
- Strong knowledge of clinical trial drug development processes, clinical trial study design, study planning and management
- Experience supporting clinical trial operations
- Previous clinical site level trial management experience is a plus
- Proficiency with MS Word, Outlook, PowerPoint, Excel
- Demonstrated interest in health or clinical research
- Ability to work in a highly collaborative environment
- Ability to listen and communicate well both verbally and in writing
- Ability to synthesize and summarize complex information
- Ability to work independently
- Attention to detail and accuracy
- Ability to handle regular changes to priorities, interruptions to independent work due to meetings, and multiple tasks ongoing simultaneously
- Ability to have regular, reliable and predictable attendance
- Knowledge of Good Clinical Practice, Standard Operating Procedures, and applicable regulations