Clinical Trial Leader

Grünenthal Group

Aachen, Germany

Purpose of the role:

The Clinical Trial leader is accountable for delivery of all aspects of assigned clinical trials including leading Trial Management Team(s)

Your responsibilities:

  • Planning, set-up, conduct and closure of assigned clinical trial(s) including supervision and management of trial budgets, forecasts and timelines
  • Provision of operational input in trial related documents and processes, such as APO, Protocol, ICF, CRF etc. and participation in challenge boards as appropriate
  • Development and maintenance of the Sponsor Oversight Plan including (functional area) sub-plans and functional plans in close cooperation with the Trial Management Team / assigned Functional Experts (FEs)
  • Ensurance of Sponsor Oversight and effective and efficient management of all third party vendors according to the Sponsor Oversight Plan (and sub-plans)
  • Support Outsourcing & Vendor Management (OVM) in selection, contract and budget negotiation with Vendors and ensure that a good working relationship with vendors is in place
  • Lead and matrix manage the multidisciplinary Trial Management Team (TMT) to ensure that all trial deliverables are provided according to timelines, budget and quality;
  • Ensure, that Trial Master File(s) of assigned clinical trial(s) is/are inspection ready at any time
  • Accountability for continuous assessment of ‘operational’ risks reported by Functional Experts to the TMT including evaluation of the impact of anticipated, new and updated risks for the clinical trial, development and implementation of mitigation plans
  • Provide Public Disclosure Lead (PDL) with accurate information for all trial databases and tracking systems

Your profile:

  • Science degree in a life and natural sciences or healthcare is required. Advanced degree in Sciences preferred.
  • Several years related experience in a pharmaceutical company, biotech firm, or CRO is required, which should include at least 4 years of technical, operational and managerial experience in planning/start-up and executing of clinical trials
  • Proven ability to work independently and to lead a multidisciplinary trial team in a complex matrix environment (including remote staff)
  • Proven experience in developing effective relationships with Vendors
  • Thorough knowledge of GCP, project management and knowledge of global clinical development processes
  • Excellent command of English (oral and written)
  • Excellent communication, negotiation and conflict / crisis management
  • International / intercultural competence

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