Clinical Study Manager

Job content

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

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 support projects in Europe (EU). This role has responsibility to oversee initiation, progress and conduct of clinical studies with a focus on Intuitive sponsored trials. The CPM serves as a 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
• Manage and execute 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 potential 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 thorough to ensure successful outcome.
• Works with data management and statisticians as needed for assigned projects.
• Ensures adherence to safety reporting requirements per local and national and European regulations.
• Maintain study documentation with or without the help of a CRA and/or clinical study coordinator (e.g. correspondence, CRFs, deviations, budget information).
• 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.
• Prepares all project status updates and power point presentations for reporting to internal stakeholders for all assigned projects.
• Prepares reports in support of external physician steering/advisory committees as needed.
• Manages publication development to submissions for studies.
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines).
• Ensure audit readiness of clinical projects to relevant regulatory and legal standards.
• Management of 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.
• Manage CRAs and support their activities as required.
• Review and approval of all site monitoring visit reports. Follow 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 as required.
• On-site monitoring should the need arise due to special conditions.
• General participation of meetings, reporting and adherence with Intuitive Surgical policies.
• Review and develop internal processes e.g. SOPs.
• Track Investigator Initiated Trails projects under the Intuitive research grant program.
  

Required Knowledge, Skills, And Experience

• Graduate qualification in Life Sciences, medicine or medical sciences. A PhD qualification is an advantage.
• Experience working in medical device industry in the clinical affairs/research function with evidence of full project management responsibility for at least five years. A minimum of three years’ experience of full project management of European pre-CE mark clinical trials is required.
• Knowledge of applicable medical device regulations and guidelines: GCP, ISO-14155, MEDDEV, MDR and Data protection rules in EU.
• Protocol and CRF development experience for both pre and post CE mark trials is required.
• Strong numerical and literary analytic skills - ability to assess data and literature quickly.
• Experience reviewing clinical data sets to evaluate data quality and address issues as needed is required.
• Experience of studies with health economic focus is an advantage.
• Experience of managing CRO’s or external consultants is preferred.
• Experience of publishing clinical research (own or in clinical industry capacity) is an advantage.
• Excellent communication and interpersonal skills with strong influencing abilities.
• Ability to work independently and across teams whilst keeping open communication with key stakeholders.
• Experience working as a Clinical Research Associate with evidence of at least two to three years of on-site monitoring is required.
• English language required, a second European language (Dutch, French, German) is an advantage.
• Comfortable in a hospital/surgical environment.
• Ability to travel a minimum of 50% throughout Europe is required.
• Ability to manage a minimum of three clinical research projects across different surgical disciplines is required.
  

Shift : Shift 1 - Day

Travel : Yes, 50 % of the Time

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