Clinical Study Manager III
Are you a talented and experienced Clinical Study Manager looking for a new and exciting opportunity? Look no further than Intuitive Surgical! As a global leader in robotic-assisted surgical technology, we are seeking a highly motivated Clinical Study Manager III to join our team. In this role, you will have the opportunity to lead and manage clinical studies that contribute to the development and improvement of our revolutionary surgical systems. We are seeking a self-driven individual with a strong background in clinical research and a passion for making a positive impact in the healthcare industry. If you are ready to take on a challenging and rewarding position with a dynamic and innovative company, we encourage you to apply for this role today.
- Lead and manage clinical studies to support the development and improvement of Intuitive Surgical's robotic-assisted surgical technology.
- Develop and implement study protocols, timelines, and budgets in collaboration with cross-functional teams.
- Oversee the collection, analysis, and interpretation of clinical data to ensure accuracy and quality.
- Coordinate and communicate with study sites, investigators, and study team members to ensure study objectives are met.
- Ensure compliance with all applicable regulations and guidelines, including FDA regulations, ICH-GCP, and local requirements.
- Manage study contracts, vendor selection, and budget negotiations.
- Develop and maintain relationships with key opinion leaders and external stakeholders.
- Communicate study progress and results to internal and external stakeholders, including senior management.
- Identify and mitigate potential risks and issues that may impact study timelines or outcomes.
- Mentor and train junior staff members on study management best practices.
- Continuously evaluate and improve study processes to increase efficiency and quality.
- Stay current with industry trends and developments in clinical research to guide study design and execution.
- Collaborate with cross-functional teams, including R&D, Regulatory Affairs, and Marketing, to ensure alignment of study objectives with overall company goals.
- Travel to study sites and attend conferences and meetings as needed.
- Represent Intuitive Surgical in a professional and positive manner at all times.
Advanced Degree In Science Or Related Field: A Clinical Study Manager Iii At Intuitive Surgical Is Expected To Have An Advanced Degree In A Scientific Or Related Field Such As Biology, Biochemistry, Or Medicine. This Education Background Ensures A Strong Understanding Of The Clinical Research Process And Medical Device Development.
Minimum Of 5 Years Of Experience In Clinical Research: A Clinical Study Manager Iii Should Have At Least 5 Years Of Experience In Clinical Research, Preferably In The Medical Device Industry. This Experience Demonstrates A Thorough Understanding Of The Regulations And Guidelines For Conducting Clinical Studies.
Knowledge Of Fda Regulations And Ich Guidelines: Intuitive Surgical Is A Medical Device Company That Must Comply With Fda Regulations And Ich Guidelines. A Clinical Study Manager Iii Should Have A Strong Understanding Of These Regulations And Guidelines To Ensure The Company's Clinical Studies Are Conducted Ethically And In Compliance With All Requirements.
Project Management Skills: As A Clinical Study Manager Iii, This Role Requires Strong Project Management Skills To Oversee Multiple Clinical Trials Simultaneously. This Includes Managing Timelines, Budgets, And Resources Effectively, As Well As The Ability To Problem-Solve And Make Decisions Under Pressure.
Strong Communication And Leadership Abilities: A Clinical Study Manager Iii Must Have Excellent Communication Skills To Effectively Collaborate With Cross-Functional Teams, As Well As To Communicate Study Updates And Results To Internal And External Stakeholders. Additionally, Strong Leadership Abilities Are Necessary To Lead And Motivate Study Teams And Ensure The Successful Execution Of Clinical Studies.
Communication Skills
Project Management
Vendor Management
Data Analysis
Time Management
Budget management
Quality Control
Team Leadership
Risk assessment
Regulatory compliance
Clinical Trials
Protocol Development
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Clinical Study Manager III in Sunnyvale, CA, USA is $130,000 to $160,000 per year. This can vary based on factors such as experience, education, and the specific company or organization the individual is working for.
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Intuitive Surgical Inc. is an American corporation that develops, manufactures and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery, most notably with the da Vinci Surgical System.
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