Clinical Project Manager 3

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.

Job Description

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 f