Program Director/Senior Clinical Project Manager
Celerion
Vienna, Austria
vor 11 Tg.

Description

Celerion is the leading global provider of outsourced early clinical research services. Customers include the leading global pharmaceutical companies as well as a number of biotechnology and small to midsized pharmaceutical companies.

provides these services through three clinical research units ( Phase I units ) with over 600 beds located in the US and Europe.

In addition, Celerion provides clinical research services through partnerships with other clinical research units in North America, Europe and Asia.

Supporting our clinical work are two world class bioanalytical laboratories located in Europe and the US.

Celerion compliments the above services by a specialized department, which coordinates complex global studies, patient studies, and vaccination trials.

Our focus is on the development of innovative pharmaceuticals with the goal of enabling companies to reach early decisions concerning which compounds to progress further into clinical development.

Services include :

  • Early Clinical Research and studies required to support product labeling
  • Data Management and Biometrics (modeling and simulation, study design and protocol development, clinical data management, biostatistics, PK / PD, medical writing and reporting)
  • Bioanalytical Services (discovery to late stage services with capabilities in small and large drug, metabolite and biomarker molecules)
  • Drug Development Services (Regulatory affairs and drug development consultancy)
  • Global Clinical Development including global multi-site studies conducted outside of Celerion clinics
  • Celerion sites are located in North America, Europe and Asia as follows : U.S. Lincoln, Nebraska; Phoenix, Arizona; Philadelphia, PennsylvaniaCanada Montreal, QuebecEurope Belfast, Northern Ireland;
  • Zurich, Switzerland; Vienna, Austria; Berlin, GermanyAsia Seoul, Korea; Singapore, Indonesia

    U.S. Canada Europe Asia

    For our Global Clinical Development Department we are looking for aProgram Director / Senior Clinical Project Manager (m / f)

    The main responsibility of the Program Director / Senior Clinical Project Manager (PDir / sCPM) is to lead the Celerion and Client teams in a project or portfolio of projects, by combining deep clinical research experience with insight into client pressures in order to develop the right solution for the client.

    This requires in-depth project management skills and business understanding, knowledge, and experience in order to independently make effective decisions and take action.

    Key Accountabilities :

  • High-end clinical project management (budget, resources, compliance, decision-making level) and managing multiple projects / studies
  • Manage Study Teams within Celerion in the area of clinical trials, clinical investigations, and other interventional or non-
  • interventional studies, in adherence to Good Clinical Practice, international standards, and regulatory requirements

  • Accountable for review and oversight of internal and external study budgets in cooperation with other Celerion departments as applicable (Finance, Contract Management)
  • Accountable for review and oversight of internal and external study timelines in cooperation with other Celerion departments as applicable (Finance, Contract Management)
  • Responsible for the supervision and the performance of the projects / studies with regards to the quality standards of Celerion and / or clients wherever applicable
  • Responsible for the supervision and the performance of the projects with regards to budget adherence and resource allocation
  • In addition, may be responsible to directly manage projects / studies as per Clinical Project Manager role
  • Knowledge / Skills / Education :

  • Bachelor’s degree in a science / medical-related field or equivalent field
  • Preferably about 7 years prior experience in project management, clinical research, or contract research organization
  • Preferably about 5 years prior employment-related experience in project scheduling, managing resources and coordinating team activities
  • Strong command of written and spoken English language, local language proficiency as required
  • Competencies in Project Planning, Project Execution, Project Fulfillment, Financial Management, Risk Management, Quality Management, Team Leadership, Communication, Relationship Management
  • Excellent knowledge of all operational and regulatory aspects of clinical research
  • A flexible attitude with respect to work assignments and new learning
  • Solid clinical knowledge and understanding of clinical research and protocol design
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