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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 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, based at Intuitive Surgical’s 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 Ethics Committee submissions with follow thorough to ensure a 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 CRA and/or clinical study coordinator.
  • 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.
  • Supports the selection of participants to physician advisory boards, safety committees and supports the conduct of such meetings.
  • 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 if the need arise.
  • General participation of meetings, reporting and adherence with Intuitive Surgical policies.
  • Review and develop internal processes e.g., SOPs.
  • Track Investigator Initiated Trials projects under the Intuitive research grant program.
  • Builds and maintain relationships to key opinion leaders and supports the management of research discussions.
  • Supports and provides additional training to CRAs and CTCs.
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Confirmed 9 hours ago. Posted 30+ days ago.

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