Primary Function:

• The Clinical Project Manager role requires a candidate with extensive experience supporting evidence generation strategy and execution of clinical studies and registries.
• This role will develop strategies for clinical and outcomes research studies to support regulatory approvals.
• Responsible for working with key stakeholders to design and develop clinical protocols and execute clinical studies (primarily premarket) with minimal supervision.
• The candidate will be required to work closely with data management and biostatistics to review and interpret results of clinical studies and to develop a clinical study report or support the development of clinical publications and regulatory submissions.
• The ideal candidate will have experience previously managing premarket studies in the United States and utilizing resources to research/scope a topic and to provide recommendations on clinical trial strategy.
• The candidate is also expected to have experience in reviewing, interpreting, and summarizing clinical literature.

Roles and Responsibilities:

• Responsible for leading pre-market clinical research activities.
• Collaborate with internal stakeholders and Key Opinion Leaders (KOLs) to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives.
• Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, creation of study related documents (protocols, case report forms, informed consents, clinical trial agreements, monitoring plan), organizing Institutional Review Board (IRB) / Ethics Committee (EC) submissions with follow thorough to ensure successful outcome.
• Responsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliance.
• Interact with external vendors and sites to negotiate contracts and budgets.
• Track study progress and provide status report on a weekly basis.
• Participate in data analysis, interpretation and synthesis, instruction in order to develop clinical study report and /or support development of scientific publications.
• Organize and lead major study meetings and activities.
• Identify risks and escalate to key stakeholders as necessary.
• Collaborate and mentor junior clinical project manager(s) and clinical research associates.
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., 21 CFR Part 312, GCP and US and OUS guidelines).
• Conduct literature reviews to stay abreast of scientific knowledge and to determine evidence gaps.
• Critically appraise scientific literature and write clinical summaries to assist research efforts and in development of clinical strategies and clinical investigational protocols.
• Review and revise Clinical Operations Standard Operating Procedures (SOPs) to assist leadership with continuous process improvement initiatives.
• Collaborate with commercial groups (i.e., marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities.
• Model and champion Intuitive’s culture and value set in your actions language and results. Focus on the “vital few” that allows for exceeding customer’s expectation.

Skill/Job Requirements:

• Minimum Advanced degree in a scientific/bioengineering field (M.S., Ph. D or M.D.) or Bachelor’s degree in a scientific/bioengineering field with 6-8 years of experience in research project management is preferred.
• Previous experience implementing, supporting, and managing drug trials.
• Significant knowledge of clinical and outcomes research study design is necessary
• Strong 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.
• Strong experience in protocol development; writing clinical section(s) for regulatory submission.
• Possess knowledge of Good Clinical Practice ICH/GCP and other applicable regulations.
• Comfortable in a hospital environment, with experience working with nurses and investigators (5-8 years).
• Basic understanding of statistics, statistical methods, and design of experiment is a requirement.
• Must be able to manage multiple projects.
• Must be able to work effectively on cross-functional teams.
• Strong communication, presentation, and interpersonal skills with high attention to detail and organization.
• Ability to learn quickly and self-educate on different surgical specialties as applicable to clinical projects (Self-starter attitude).
• Strong work-ethic to support aggressive timelines or multiple projects as required.
• Must be able to travel up to 25%.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

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.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.