Intuitive
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Clinical Study Manager III
role at
Intuitive This range is provided by Intuitive. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$103,000.00/yr - $174,400.00/yr Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare\'s hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let\'s advance the world of minimally invasive care. Primary Function of the Position This position requires a candidate with extensive experience in evidence generation strategy and the execution of clinical studies. The Clinical Study Manager-3 (CSM III) will develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, the role will design and develop clinical protocols and execute clinical studies (pre-market or post-market) with minimal supervision. The candidate will work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for conduct and execution of the study, as well as with biostatisticians to review and interpret results, develop clinical study reports, and assist with clinical publications. During trial execution, the CSM will drive progress from site selection through enrollment and follow-up, provide guidance to monitors on monitoring needs, and oversee compliance work on the study. The CSM will take a leadership role in external communication with investigators and study teams. The ideal candidate will have experience managing premarket studies in the United States and using resources to research and scope topics and provide recommendations on clinical trial strategy. The candidate is also expected to have experience reviewing, interpreting and summarizing clinical literature. Essential Job Duties
Lead assigned clinical research activities Partner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocols and study outlines, and drive identified initiatives Plan and execute clinical studies including site selection, recruitment projections, and creation of study documents (protocols, case report forms, informed consents, study reports); organize IRB/EC submissions to ensure timely progress Conduct clinical studies on schedule and within budget while ensuring high quality and compliance Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close-out visits Monitor regulatory and protocol compliance and data accuracy in accordance with the monitoring plan Complete source data verification of data in EDC systems or CRFs to ensure regulatory compliance and data integrity Liaise with sites and assist in internal audits/inspections; ensure sponsor audit readiness Negotiate contracts and budgets with external vendors and sites in partnership with legal and management Track study progress and provide regular status reports Collaborate with Biostatisticians on data analysis and reporting; support development of clinical study reports and publications Manage site payments and assist in study financial tracking; develop tracking tools as needed Organize and drive study meetings and other activities; mentor junior team members Adhere to SOPs and regulatory requirements (GCP, US and international guidelines) and proactively manage studies Conduct literature searches and appraise scientific literature to inform research and strategies Review and revise Clinical Operations SOPs to support continuous process improvement For post-market research, collaborate with commercial teams to understand market trends and support business goals; provide HEOR input for outcomes research Work with investigators to prepare manuscripts, abstracts, slides, and posters Support regulatory submissions and respond to regulator questions on study design and results Qualifications
Required Skills and Experience
Experience implementing, assisting and managing medical device trials Strong knowledge of clinical and/or outcomes research study design Experience in protocol and ICF development and regulatory submissions Proven ability to perform literature searches and appraise scientific data Excellent communication and collaboration with physicians and professionals Knowledge of ICH/GCP and applicable regulations; understanding of monitoring requirements Experience negotiating clinical contracts and budgets Ability to work effectively on cross-functional teams Willingness to travel 25-40% (or per business needs) Capability to manage multiple projects and shifting priorities Strong communication, presentation and relationship-building skills with attention to detail Ability to learn quickly and adapt to new surgical specialties as needed Experience leading a project team of CRAs and CTAs; provide study updates to management Demonstrated work ethic, problem-solving mindset, and ability to meet timelines Required Education And Training
Advanced degree in a scientific/bioengineering field (M.S., Ph.D., or M.D.) with 3-4 years of clinical research experience, or a Bachelor\'s degree with 5 years of clinical research experience (preferred) Preferred Skills And Experience
Experience in a hospital environment; familiarity with nurses and surgeons preferred Knowledge of statistics, statistical methods, and experimental design is highly preferred Additional Information: Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider qualified applicants with arrest and conviction records in accordance with fair chance laws. Intuitive provides market-competitive compensation packages, including base pay, incentives, benefits, and equity. Actual pay will be determined based on experience, skills, and qualifications. The base salary ranges listed are for reference. Base Salary Range Region 1: $121,200 - $174,400 Base Salary Range Region 2: $103,000 - $148,200 Shift: Day Workplace Type: Purposeful Onsite - This job requires onsite presence for leader-defined events and activities, which could be monthly or annually. Onsite frequency may increase based on business need. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Medical Equipment Manufacturing Note: This refined description retains the core responsibilities, qualifications, and company information while removing boilerplate, unrelated postings, and duplicative content. It uses only allowed tags and avoids unnecessary formatting.
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Clinical Study Manager III
role at
Intuitive This range is provided by Intuitive. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$103,000.00/yr - $174,400.00/yr Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare\'s hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let\'s advance the world of minimally invasive care. Primary Function of the Position This position requires a candidate with extensive experience in evidence generation strategy and the execution of clinical studies. The Clinical Study Manager-3 (CSM III) will develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, the role will design and develop clinical protocols and execute clinical studies (pre-market or post-market) with minimal supervision. The candidate will work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for conduct and execution of the study, as well as with biostatisticians to review and interpret results, develop clinical study reports, and assist with clinical publications. During trial execution, the CSM will drive progress from site selection through enrollment and follow-up, provide guidance to monitors on monitoring needs, and oversee compliance work on the study. The CSM will take a leadership role in external communication with investigators and study teams. The ideal candidate will have experience managing premarket studies in the United States and using resources to research and scope topics and provide recommendations on clinical trial strategy. The candidate is also expected to have experience reviewing, interpreting and summarizing clinical literature. Essential Job Duties
Lead assigned clinical research activities Partner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocols and study outlines, and drive identified initiatives Plan and execute clinical studies including site selection, recruitment projections, and creation of study documents (protocols, case report forms, informed consents, study reports); organize IRB/EC submissions to ensure timely progress Conduct clinical studies on schedule and within budget while ensuring high quality and compliance Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close-out visits Monitor regulatory and protocol compliance and data accuracy in accordance with the monitoring plan Complete source data verification of data in EDC systems or CRFs to ensure regulatory compliance and data integrity Liaise with sites and assist in internal audits/inspections; ensure sponsor audit readiness Negotiate contracts and budgets with external vendors and sites in partnership with legal and management Track study progress and provide regular status reports Collaborate with Biostatisticians on data analysis and reporting; support development of clinical study reports and publications Manage site payments and assist in study financial tracking; develop tracking tools as needed Organize and drive study meetings and other activities; mentor junior team members Adhere to SOPs and regulatory requirements (GCP, US and international guidelines) and proactively manage studies Conduct literature searches and appraise scientific literature to inform research and strategies Review and revise Clinical Operations SOPs to support continuous process improvement For post-market research, collaborate with commercial teams to understand market trends and support business goals; provide HEOR input for outcomes research Work with investigators to prepare manuscripts, abstracts, slides, and posters Support regulatory submissions and respond to regulator questions on study design and results Qualifications
Required Skills and Experience
Experience implementing, assisting and managing medical device trials Strong knowledge of clinical and/or outcomes research study design Experience in protocol and ICF development and regulatory submissions Proven ability to perform literature searches and appraise scientific data Excellent communication and collaboration with physicians and professionals Knowledge of ICH/GCP and applicable regulations; understanding of monitoring requirements Experience negotiating clinical contracts and budgets Ability to work effectively on cross-functional teams Willingness to travel 25-40% (or per business needs) Capability to manage multiple projects and shifting priorities Strong communication, presentation and relationship-building skills with attention to detail Ability to learn quickly and adapt to new surgical specialties as needed Experience leading a project team of CRAs and CTAs; provide study updates to management Demonstrated work ethic, problem-solving mindset, and ability to meet timelines Required Education And Training
Advanced degree in a scientific/bioengineering field (M.S., Ph.D., or M.D.) with 3-4 years of clinical research experience, or a Bachelor\'s degree with 5 years of clinical research experience (preferred) Preferred Skills And Experience
Experience in a hospital environment; familiarity with nurses and surgeons preferred Knowledge of statistics, statistical methods, and experimental design is highly preferred Additional Information: Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider qualified applicants with arrest and conviction records in accordance with fair chance laws. Intuitive provides market-competitive compensation packages, including base pay, incentives, benefits, and equity. Actual pay will be determined based on experience, skills, and qualifications. The base salary ranges listed are for reference. Base Salary Range Region 1: $121,200 - $174,400 Base Salary Range Region 2: $103,000 - $148,200 Shift: Day Workplace Type: Purposeful Onsite - This job requires onsite presence for leader-defined events and activities, which could be monthly or annually. Onsite frequency may increase based on business need. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Medical Equipment Manufacturing Note: This refined description retains the core responsibilities, qualifications, and company information while removing boilerplate, unrelated postings, and duplicative content. It uses only allowed tags and avoids unnecessary formatting.
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