Clinical Study Manager II

Sunnyvale, California

Posted in Manufacturing and Production

This job has expired.

Job Info

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 Position:

This position reports to the Manager, Clinical Affairs, and requires a candidate with experience supporting evidence generation strategy and execution of clinical studies. The Clinical Study Manager will support the manager in developing strategies for clinical and outcomes research studies to support regulatory approvals. As a member of the team, this role will be responsible for working with keys internal and external stakeholders to design and develop clinical protocols, and execute clinical studies with some supervision. The candidate will be required to work closely with data management and biostatistics to review results of clinical studies and to develop or support the development of a clinical study report or clinical publications. The ideal candidate will have experience previously managing clinical studies in the United States and utilizing resources to research and scope a research topic. The candidate is also expected to have experience in reviewing, interpreting and summarizing clinical literature.

Roles & Responsibilities:

  • Responsible for leading pre and post market clinical research activities
  • Collaborate with internal stakeholders and 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 IRB/EC submissions with follow thorough to ensure successful outcome
  • Responsible for conducting clinical studies on schedule and within budget while ensuring high quality and compliance.
  • Liaise 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 or support the development of clinical study report and /or of scientific publications
  • Organize and lead major study meetings and activities
  • Identify risks and escalate to key stakeholders as necessary
  • Collaborate with other clinical study manager(s) and clinical research associates
  • Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US guidelines)
  • Conduct literature searches 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 investigational protocols.
  • Assist Clinical Affairs 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
  • Provide scientific expertise for preparation of manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications.

Skills, Experience, Education, & Training:

  • Advanced degree in a scientific/bioengineering field (M.S., Ph. D or M.D.) or Bachelor's degree in a scientific/bioengineering field with up to 2 years of experience in clinical affairs/research project & study management is preferred
  • Previous experience implementing, supporting and managing device trials
  • Significant knowledge of clinical and outcomes research study design is preferred
  • 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.
  • Some 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 surgeons a plus.
  • Basic understanding of statistics, statistical methods, and design of experiment is a requirement
  • Must be able to work effectively on cross-functional teams.
  • Must be able to travel up to 10-20%
  • Must be able to manage multiple projects
  • 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)
  • Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary

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.

Shift : Shift 1 - Day

Travel : Yes, 25 % of the Time

Travel Requirements:Yes, 25 % of the Time Shift:Shift 1 - Day

This job has expired.

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