Senior Clinical Study Manager

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 purpose of this job function is to serve as a Clinical Project Manager (CPM) in the Clinical Affairs Department to manage projects in Europe (EU). This role has responsibility for the initiation, progress and conduct of clinical studies with a focus on Intuitive sponsored trials. The CPM serves as the primary contact to all parties involved in the project, internal and external.

The candidate will ensure clinical trial conduct in compliance with applicable laws, regulations MDD/MDR, ISO14155, guidance Good Clinical Practices (GCP), and Intuitive Surgical SOPs. This position will report to Clinical Affairs, Europe Intuitive Surgical Headquarters, in Switzerland

Roles and Responsibilities:

This position has responsibility and authority for:

• Intuitive Surgical Sponsored Studies
  • Manages and executes clinical research activities essential to the successful conduct of pre- and post-market clinical studies in EU.
  • Responsible for the management of the clinical studies including project development, budget, investigator selection, analysis of patient recruitment, preparation of study related documents (protocols, case report forms, informed consents, clinical trial agreements), organizing Competent Authority and Ethic Committee submissions with follow through to ensure successful outcome.
  • Manages ongoing study activities, enrolment, safety reporting, troubleshooting etc.
  • Works with data management and statisticians as needed for assigned projects.
  • Ensures adherence to safety reporting requirements per local and national and European regulations.
  • Supervises the maintenance of study documentation managed by the Clinical Research Associate (CRA) and/or Clinical Trial Coordinator (CTC).
  • Plans and manages the project timelines to ensure clinical studies are conducted in a timely manner and within the project budget.
  • Proactively anticipates and understands concerns/issues/delays in the project and develops risk assessment and contingency plans and executes these.
  • Prepares all project status updates and power point presentations for reporting to internal stakeholders for all assigned projects.
  • Supports the selection of participants to physician advisory boards, safety committees and supports the conduct of such meeting.
  • Manages publication development to submissions for studies and supports internal medical marketing from publications.
  • Ensures compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines).
  • Ensures audit readiness of clinical projects to relevant regulatory and legal standards.
  • Manages Contract Research Organization (CRO) or independent clinical service providers, e.g., identification of suitable partner(s), development of contracts or work charter and interactive management of entity to ensure project success.
• Manages CRAs and supports their activities as required.
• Reviews and approves all site monitoring visit reports. Follows up with the assigned CRA to ensure clear and concise trip reports and relevant site trouble-shooting issues are addressed in a timely manner.
• Co-monitoring with the assigned CRA for additional quality control if the need arises.
• General participat