Senior Clinical Project Manager

Position summary

Responsible for efficient implementation, execution and reporting of assigned clinical projects in accordance with protocol, timelines, and approved budget.
Manage the efficient operational day-to-day activities of clinical projects and ensure protocol and ICH-GCP compliance.
Proactively identify risks to project timelines and budgets, propose risk mitigation and contingency plans.

Key Activities and Responsibilities

  • Review of protocols and other essential documents (e.g. CTR, IB, DSUR)
  • Develop and/or contribute to the development of project specific procedures, manuals and instructions
  • Participate in preparation, tracking and forecasting of timelines, milestones and deliverables
  • In collaboration with Project Directors, oversee and manage budget to ensure project remain with contractual obligations
  • Supervise CRO/vendor performance
  • Define, track and report metrics (e.g. schedules, milestones, critical path) to provide continual visibility of status and deliverables
  • Identify and manage potential recruitment or operational issues - assist in problem resolution efforts such as protocol amendments.

Competences, Skills and Qualification

  • Bachelor's Degree is required, advanced degree is preferred
  • 5+ years of clinical trial manager experience within the biotech or similar industry
  • Profound knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
  • Global and Phase I-III trial experience is required
  • Oncology experience is required
  • Strong clinical project manager skills
  • Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met
  • Excellent communication skills to effectively disseminate information to project team and outside parties.

Location

Basel, Switzerland

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