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 pioneer and leading company in the field of 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.

Job Description

Primary Function of Position:

The Future Forward Global Clinical Research Manager will be a pivotal leader in helping shape the clinical strategy and guiding the design of clinical studies and building strategic clinical evidence to drive product innovation and development. This role focuses on leveraging clinical data and insights to inform product design and development, ensuring that new medical technologies are optimized for patient outcomes and regulatory success. The ideal candidate has deep expertise in translating clinical research insights into strategic product decisions and a strong background in developing clinical protocols for novel technologies.

Roles and Responsibilities:

Clinical Trial Design, Development and Management:

• Cross-functional collaboration with key internal and external stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision.

• Oversight study conduct and execution including data management, including direction and support for clinical research organizations (CROs), clinical research associates (CRAs), clinical trial assistants (CTAs).

• Oversight and development of all study materials including but not limited to protocols, informed consent, data collection forms, and study binders for all Company sponsored trials maintaining all global GCP requirements.

• Responsible drive the progress of the trial during site selection, site start-up and through enrolment and follow-up.

• Partnership and guidance to the study monitors about monitoring needs and oversee compliance work on the study.

• Manage Future Forward clinical research activities, including planning, execution, site selection, patient recruitment, and document creation (protocols, case report forms, informed consents, clinical trial agreements, study reports).

• Ensure Future Forward clinical studies are conducted on schedule, within budget, and in compliance with quality standards.

• Provide input to Product Development based on patient risks and clinical data.

• Serve as a liaison with research sites to ensure study compliance and progress.

• Collaborate with internal stakeholders, investigators, and KOLs to develop and review study designs, protocols, and initiatives.

• Perform site qualification, initiation visits, and audits, ensuring sponsor readiness.

• Negotiate contracts and budgets with vendors and sites, in partnership with legal and management.

• Track study progress, provide status reports, and manage site payments and financial tracking tools.

• Support study start-up, approvals, and site monitoring.

• Work with biostatisticians on data analysis, clinical study reports, and scientific publications.

• Organize study meetings and mentor junior team members.

• Ensure compliance with corporate SOPs, GCP, and regulatory guidelines.

Evidence Generation

• Build and maintain positive relationships with key opinion leaders, medical advisors, and clinical leaders.

• Collaborate with cross-functional teams to understand market trends and align clinical activities with Future Forward business goals.

• Assist in preparing manuscripts, abstracts, and presentations for scientific meetings and publications.

• Collaboration on evidence generation strategies and execution.

Post-Market Surveillance

• Support post-market research and regulatory submissions, addressing regulatory questions and ensuring clinical study compliance.

• Contribute to regulatory processes related to adverse events, product complaints, risk assessments, and recalls.

Qualifications

Required Knowledge, Skills, and Experience:

• Minimum bachelor’s degree in a life science, health sciences, nursing, or related field

• Minimum of 5-10 years of experience in clinical research is preferred.

• Proven track record in the development and execution of global clinical research and evidence generation.

• Experience and successful track record with innovative medical technologies and novel interventions.

Required Skills and Experience:

• Previous experience implementing, helping and managing medical device trials, preferably for innovative or emerging technologies.

• 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”).

• Ability to manage and motivate project teams consisting of CRAs and CTAs and support management with relevant study updates.

• Exhibits solid work ethic to help meet tight timelines or multiple projects, when necessary, with a problem-solving mindset.

Preferred Skills and Experience:

• Accustomed to working in a hospital environment, experience working with nurses and surgeons preferred.

• Working knowledge or experience with global regulations related to clinical studies and submissions to regulatory authorities.

• Experience presenting and providing clinical education on medical technology to both medical and non-medical personnel.

• Broad knowledge in surgical and endoscopic procedures.

• Evidence of work style characterized by vision, teamwork, preparation, communication and negotiation.

• A history of successfully managing relationships at all levels of the organization.

• Results-oriented individual, skilled in motivating and inspiring people.

• Good oral and written communication skills for both scientific and non-scientific groups.

• Effective analytical and problem-solving skills with the ability to manage multiple projects and apply creative solutions to challenges.

• Commitment to patient safety and professional ethics as top priority

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 for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.