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Senior Clinical Study Manager

Company Description

Unternehmensbeschreibung

Bei Intuitive setzen sich alle Beteiligten vereint für unsere Mission ein: Wir sind der Auffassung, dass minimalinvasive Behandlung die Behandlungsform ist, die Lebensqualität steigert. Durch Einfallsreichtum und intelligente Technologie erweitern wir das Potenzial von Ärzten, ohne Einschränkungen zu heilen.

Als Pionier und Marktführer im Bereich roboterassistierte Chirurgie streben wir danach, ein integratives und vielfältiges Team aufzubauen, das sich dafür einsetzt, etwas zu bewirken. Seit mehr als 25 Jahren arbeiten wir mit Krankenhäusern und Pflegeteams auf der ganzen Welt zusammen, um die größten Herausforderungen des Gesundheitswesens zu meistern und die Grenzen des Möglichen zu verschieben.

Das Fundament von Intuitive wurde durch die Bemühungen großartiger Menschen mit unterschiedlichen Hintergründen geschaffen. Wir sind der Auffassung, dass großartige Ideen von überall kommen können. Deshalb streben wir danach, eine integrative Kultur zu fördern, die auf vielfältigen Denkweisen und gegenseitigem Respekt basiert. Unser Führungskonzept beruht auf Inklusion und wir versetzen die Mitglieder unseres Teams in die Lage, bestmögliche Leistungen zu erbringen, indem sie ihr authentisches Selbst einbringen.

Unsere Unternehmenskultur wird vorangetrieben von leidenschaftlichen Menschen, die etwas bewirken wollen: die Mitglieder unseres Teams handeln gemäß den Grundsätzen der Integrität, weisen eine hohe Lernfähigkeit auf und setzen sich energisch dafür ein, Aufgaben zu bewältigen und vielfältige, praxisnahe Erfahrungen zu sammeln, die uns helfen, neue Denkansätze einfließen zu lassen. Wir investieren aktiv in die Mitglieder unseres Teams, um ihr langfristiges Wachstum zu fördern, damit sie unsere Mission weiter vorantreiben und ihr Potenzial voll ausschöpfen können.

Schließen Sie sich einem Team an, das sich dafür einsetzt, bedeutende Fortschritte für die globale Gemeinschaft von medizinischen Fachkräften und ihren Patienten zu erzielen. Bringen wir gemeinsam den Bereich der minimalinvasiven Behandlungsformen voran!

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 participation of internal and external meetings, reporting and adherence with Intuitive Surgical policies.
  • Keeps up to date knowledge of the requirements on clinical trial processes. Reviews and develops internal processes e.g., SOPs.
  • Supports and tracks Investigator Initiated Trials projects established under the Intuitive research grant program.
  • Builds and maintains relationships to key opinion leaders and supports the management of research discussions.
  • Supports, trains and may oversees CPMs and CRAs and CTCs

Qualifications

Required Knowledge, Skills, and Experience:

  • Experience of studies with health economic focus is an advantage.
  • Experience of managing CRO’s or external consultants
  • Experience of publishing clinical research (own or in clinical industry capacity)
  • 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 CRA with evidence of at least one to two years of on-site monitoring is an advantage.
  • English language required; a second European language (Dutch, French, German) is an advantage.
  • Comfortable in a hospital/surgical environment
  • Ability to travel up to 25% throughout Europe is required.

Additional Information

Intuitive ist ein Arbeitgeber, der gleiche und gerechte Beschäftigungsmöglichkeiten bietet. Wir bieten allen qualifizierten Bewerbern und Mitarbeitern gleiche Beschäftigungsmöglichkeiten, unabhängig von ethnischer Herkunft, Geschlecht, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität, nationaler Herkunft, Hautfarbe, Alter, Religion, geschütztem Veteranenstatus, Behindertenstatus, genetischen Informationen oder einem anderen Status, der nach den geltenden Gesetzen auf Bundes-, Landes- oder lokaler Ebene geschützt ist, und verbieten jegliche Form von Diskriminierung und Belästigung.

Gemäß den „Fair Chance“-Gesetzen berücksichtigen wir qualifizierte Bewerber, die verhaftet wurden oder Vorstrafen haben, für offene Stellen.

Shift: Day
Travel: 25% of the time

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