Senior Project Manager

Job overview

We are always interested to get in contact with Senior Project managers. The Senior Project Manager ensures an efficient planning and coordination of complex (multi)national clinical trials in accordance with SOP legislation and regulations and ICH/GCP guidelines.

Tasks & responsibilities

  • Starts-up/manages (complex) clinical trials in accordance with all relevant guidelines, legislation and SOPs
  • Writes or ssists in the writing of a Project Management Plan
  • Develops study-specific documentation (in cooperation with Quality, Training and Compliance department)
  • Monitors the progress of the clinical trial against the project plan and previously defined performance indicators in terms of quality, quantity and budget, and adjusts implementation as necessary
  • Reports progress made to the sponsor, the next level internally and the study’s Steering Committee (if applicable)
  • Plans, organises and participates in meetings for investigators, CRAs, etc.
  • Coordinates the activities of the project team and identifies capacity problems with respect to the individual and team workload
  • May act as a point of contact for the sponsor and all members of the project team
  • Provides prompt and clear information to all members of the project team and the sponsor with regard to study activities, upon which appropriate and quick decisions can be made with regard to the organisation and implementation of the trial
  • Manages the study costs in accordance with the sponsor contract and the budget
  • Works together with Julius Clinical’s legal advisors when site/investigator contracts, vendor and partner contracts have to be negotiated and executed
  • Acts as line manager for the Clinical Operations staff on the assigned trial, including goal setting, coaching and performance evaluation
  • Contributes to process improvements, e.g. professionalisation of work activities, methods of reporting, implementation of new legislation and regulations



Desired Skills & Expertise

  • Higher level of education, preferably in a biomedical field
  • Up-to-date knowledge of legislation and regulations and ICH/GCP guidelines
  • A minimum of 5 years’ experience in the pharmaceutical and/or CRO industry
  • Preferably a minimum of 2 years’ experience as a (junior) Project Manager
  • Experience in the theraputic area Oncology and/or Alzheimer's is an advantage
  • Experience in line management is preferable
  • Certification in project management is preferable


    Additional Information

    Posted
    September 20, 2017
    Type
    Full-time
    Experience
    Mid-senior
    Functions
    Clinical Operations

    How to apply

    Are you interested in this position? Send your CV and motivation letter to vacancies@juliusclinical.com. If you have further questions you can contact Chantal van der Meeren, Recruiter, at +31 (0)30 656 9900.