Clinical Project Manager

Vor 2 Tagen

Zürich, Schweiz TN Switzerland Vollzeit

Clinical Project Manager, 100%

As the main R&D work is being wrapped up, my client in Zurich is in need of a Clinical Project Manager to support outsourced studies on a global level. We are preferring candidates who have experience with infectious diseases/vaccine development and dealing in Phase I & II studies.

Key Responsibilities:

  • Leading and managing clinical trials to ensure adherence to scope, quality, budget, timelines and performing regular risk assessments.
  • Designing regulatory strategy, clinical trial design and development plans with support from the Clinical Director.
  • Analyzing, interpreting and presenting clinical data internally and externally. Discussing key findings with statisticians and conducting data checks, data queries and database integrity assignments.
  • Managing and preparing ethical and regulatory submissions.
  • Identifying, coordinating and supporting the development of clinical assays with external partners and/or clinical sites. Keeping samples’ database and shipments tracking.
  • Preparation and/or review of clinical study documentation (protocol, study plans and clinical study report).
  • Identifying, selecting, managing and overseeing external vendors, such as Contract Research Organizations (CROs), clinical sites, central laboratories etc. to ensure performance and deliverables.
  • Authoring, revising and/or updating SOPs, Work Instructions and other relevant documents.

You are an efficient and enthusiastic team player with:

  • Hands-on experience in successfully managing all operational aspects of clinical trials.
  • Experience in the development of study-related documents like study protocols, interim reports, final study reports, etc.
  • Experience in management of CROs, vendors and consultants.
  • Good understanding of the study application packages and the communication with ECs, IRBs and regulatory authorities like EMA, FDA, etc.
  • In-depth knowledge of ICH-GCP and experience in risk assessment and development of mitigation plans.

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.

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