Clinical Project Manager

Clinical Project Manager

CROMSOURCE

Verona or Milan, Italy

Main Job Tasks and Responsibilities:

  • Manage and coordinate assigned clinical projects
  • Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)
  • Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members
  • Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned
  • Demonstrate knowledge and follow appropriate trainings in the application process for clinical studies, in force in the courtry(ies) of work. Provide updates on the topic when needed.
  • May act as Technical Specialist supervising the projects within specific therapeutic/technical areas
  • Assure the proper timelines of the assigned projects
  • Manage the budget of the project
  • Monitor the workload and the performance of the project team
  • Plan and monitor the tasks of the team in the specific areas
  • Coordinate the Clinical Research Associates and Clinical Monitors activities, ensuring compliance with ICH-GCP guidelines and applicable laws and regulations
  • Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities
  • Collaborates with the Clinical Trial Administrators in archiving activities
  • Collaborate, in the overall management of the project, with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)
  • Assist the Medical Monitor in preparing protocols, Case Report Forms (CRFs) and final Clinical Study Reports (CSRs)
  • Deliver project specific trainings
  • Organise and participates in Monitor's and Investigator's Meetings
  • Organise and/or take part in the periodic project update meetings
  • Provide project updates to the Sponsor, the Senior Project Manager and/or Project Director/Leader
  • Inform the Project Director/Leader about any issues
  • Perform co-monitoring visits for the assigned clinical projects, if necessary
  • Carry out the monitoring of the sites for the assigned projects, when requested and if applicable
  • Act as tutor for Project Coordinators
  • May act as Feasibility Associate after appropriate and documented training
  • Maintain contact with the Sponsor to verify the consistency with contract requirements and Sponsor satisfaction
  • Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit
  • Collaborate in complying and enforcing Company procedures

Education and Experience:

  • University Degree in scientific, medical or paramedical disciplines
  • Proven experience as a Clinical Project/Study Manager or similar in the CRO/Pharmaceutical industry
  • Experience with submissions and preparation of study documentation
  • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
  • Advanced 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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