10 days old

Project -Clinical Manager 2

Intuitive Surgical, Inc.
Sunnyvale, CA 94086
  • Job Code
    REF2388P
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 of Position:

The clinical project manager role requires a candidate with experience supporting an evidence generation strategy and preferably experience with execution of clinical studies and registries. This role will develop strategies for clinical and outcomes research studies to support regulatory approvals. The clinical project manager will be responsible for working with key stakeholders to design and develop clinical trial protocols, execute pre-market clinical studies, and work closely with data management and biostatistics to review and interpret results for clinical studies, and with regulatory bodies in developing clinical study reports to be submitted to the regulatory bodies, as well as be involved in organizing clinical publications. The ideal candidate will have experience previously managing pre-market studies in the United States and utilizing resources to research/scope a topic and provide recommendations on clinical trial strategies. The candidate is also expected to have experience in reviewing, interpreting, and summarizing clinical literature. The ideal candidate for the Molecules team is a team player, is practical and is pro-active.

Roles and Responsibilities:

  • Responsible for leading pre-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 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 reports and /or support development of scientific publications.
  • Organize and lead major study meetings and activities.
  • Ensure compliance with corporate (e.g. SOP's) and regulatory requirements (e.g. 21 CFR 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 Surgical's culture and value set in your actions language and results. Focus on the "vital few" that allows for exceeding customer's expectation.
  • Work with Consultants and Regulatory Experts to create/manage a portfolio of Investigational New Drug Applications for existing and new chemical entities.
  • Review and contribute to preclinical data generation, including but not limited to pharmacologic/toxicologic GLP-compliant studies in addition to chemistry, manufacturing and controls.
  • Author and assist in the development of preclinical and clinical documents including but not limited to protocols and amendments, Investigator's Brochures, IRB applications, informed consent forms, statistical analysis plans (SAP), medical (MMP) and clinical (CMP) monitoring plans, IND submissions, clinical trial master files (TMFs), annual reports and preclinical and clinical study reports
  • Design and assist in the development and review of case report forms (CRFs), electronic data capture strategies (eDC with eCRFs) and clinical study databases
  • Monitor and report project status for milestones, documentation, and deliverables.
Qualifications
Qualifications:
  • Excellent communication, organization and interpersonal skills with strong attention to detail
  • Advanced degree in a scientific/bioengineering field (M.S., Ph.D or M.D.) or Bachelor's degree in a scientific/bioengineering field with Minimum 2-6 years of experience in clinical research is preferred
  • Previous experience 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
  • Basic understanding of statistics, statistical methods, and design of experiment is a requirement
  • Must be able to manage multiple project
  • 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 10-20%
Additional Information
All your information will be kept confidential according to EEO guidelines.

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 : Day

Travel : 10% of the time





Posted: 2022-08-02 Expires: 2022-08-31
Sponsored by:
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Sponsored by:
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Project -Clinical Manager 2

Intuitive Surgical, Inc.
Sunnyvale, CA 94086

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