A global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery.
Senior Clinical Study Manager
Location
California
Posted
6 days ago
Salary
$151.7K - $218.3K / year
Seniority
Senior
Job Description
Senior Clinical Study Manager
Intuitive
• Develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives. • Design and develop clinical protocols and execute clinical studies with minimal supervision. • Work closely with clinical research associates, clinical trial assistants, and data management for the conduct and execution of studies. • Drive the progress of the trial during site selection, site start-up and through enrollment and follow-up. • Provide guidance to monitors about monitoring needs, and oversee compliance work on the study. • Take a leadership role in external communication with investigators and study teams. • Complete source data verification of clinical study data entered in EDC system or on case report form.
Job Requirements
- Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research, or Bachelor's degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research is preferred, or a minimum of 10 years of experience in clinical research with relevant training.
- Previous experience implementing, helping and managing medical device trials
- Significant knowledge of clinical and/or outcomes research study design
- Proven experience in protocol and ICF development, writing clinical section(s) for regulatory submission
- Proven experience in conducting literature searches, reviews and appraisal of the scientific data
- Excellent ability to interact with physicians and other professionals inside and outside the company
- Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
- Experience negotiating clinical research contracts and budgets
- Must be able to work effectively on cross-functional teams
- Must be able to travel 25-40% or based on business requirements
- Must be able to manage multiple projects and/or manage different priorities
- Proven communication, presentation and relational skills with high attention to detail and organization
- Ability to learn quickly, tailor to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects (“Self-starter attitude”)
Benefits
- Health insurance
- Flexible working hours
- Professional development opportunities
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