Senior Project Manager

Senior Project Manager

CROMSOURCE

Belgium

As a Senior Clinical Project Manager you will be responsible for oversight of assigned clinical projects ensuring quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines and other applicable regulations. You may also act as Project Director/Leader, depending on the complexity of projects.

Main Tasks and Responsibilities

  • Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators and coordinating the project team members
  • Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state
  • Manages the budget of the project
  • Participates in Monitor's and Investigator's Meetings
  • Provides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.
  • Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor
  • Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations
  • Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels
  • May provide oversight and mentoring for junior staff assigned to the projects.
  • Supervises the archiving activities
  • Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)
  • Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs) and final Clinical Study Reports (CSRs)
  • Performs, if necessary, co-monitoring visits for the assigned clinical projects;
  • May act as Feasibility Associate (FEA) after appropriate and documented training
  • May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)
  • Arranges and collaborates with the assigned Clinical Research Department Director, in identifying the project specific trainings of the project team and in delivering them

Education and Experience Required

  • University Degree in scientific, medical or paramedical disciplines
  • Significant experience in clinical project management in the CRO/pharmaceutical industry
  • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
  • Fluent in English and local language(s)
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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