Intuitive Surgical Careers

Clinical Studies Project Manager - France

France
Clinical Affairs


Job Description

Job: Clinical Affairs
Primary Location: France
Schedule: Full-time
Requisition ID: 190567

Description

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 to support the product development and overall clinical-regulatory strategy.  To oversee initiation, progress and conduct clinical studies OUS, mainly in France, to ensure compliance with Good Clinical Practices (GCP), SOPs, and other applicable regulations. 
Roles and Responsibilities:
 
This position has responsibility and authority to:
  • Manage and execute clinical research activities essential to the successful management of pre and post –market clinical studies under direction from Clinical affairs manager/director.
  • Work closely with core team member to facilitate program/project strategies.
  • Responsible for the management of the clinical studies including investigator selection, analysis of potential patient recruitment, preparation of study related documents (protocols, case report forms, Informed consents,  Clinical trial agreements), organizing IRB/EC submissions with follow thorough to ensure successful outcome
  • Amend clinical study documents as needed.
  • Monitor clinical study data at sites to ensure regulatory and protocol compliance and manage CRA when applicable.
  • Manage the Contract Research Organization (CRO)- initial identification of suitable partner, development of CRO work charter and interactive management of CRO to ensure project success
  • Conduct other site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim site visits, and study close-out visits), as required.
  • Generate clear and concise trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc) and, as required, clinical summaries.
  • Manage  investigational device accountability, CRF retrieval and query distribution to sites
  • Maintain study documentation (e.g., correspondence, CRFs, deviations, budget information).
  • Ensure clinical studies are conducted in a timely manner and within site budgets.
  • Escalate issues to senior staff on a timely manner 
  • Prepare reports in support of external physician advisory committees.
  • Develop reports for submission to regulatory agencies. 
  • Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
  • Develop Clinical Evaluation reports to support technical files
  • Conduct literature searches and obtain electronic versions of articles in support of ongoing bibliography and meta-analyses / add meta-data to articles in library in order to track types of publications and extract metrics
  • Review and develop SOPs
Qualifications

Required Knowledge, Skills, and Experience:
  • Bachelor’s or Master degree or equivalent training and experience
  • Minimum of 2 years of experience as CRA and 4 years of experience as clinical project manager in the medical device industry, including projects conducted in France.
  • Knowledge of applicable medical device regulations and guidelines: GCP, ISO-14155, MEDDEV, MDR and Data protection rules in EU.
  • Excellent communication and interpersonal skills with high attention to detail and organization
  • Ability to work independently and across teams whilst keeping open communication with key stakeholders
  • Language skills: fluent in French and English, other EU languages appreciated
  • Ability to travel up to 50%
  • Ability to manage multiple projects across different surgical disciplines
  • Ability to assist in protocol development and study report writing
  • Knowledge of the Operating Room environment preferred