Associate Clinical Trial Manager

Associate Clinical Trial Manager

Seagen

Milan, Italy

Summary:

The Associate Clinical Trial Manager is the Regional Clinical Trial Operations individual responsible for the coordination of clinical operations required to initiate, execute and complete clinical trials to drive on-time delivery of clinical trial milestones. May act in support or lead role.

Principal Responsibilities:

  • May act as study lead and participate on the cross-functional study team;
  • May act as mentor for less senior RCTO staff on the study;
  • Create and maintain clinical trial documents;
  • Participate in the identification, evaluation, and selection of clinical trial sites;
  • Conduct data review;
  • Responsible for tracking of ancillary and investigational supplies, specimens and/or imaging;
  • Support CTMS and Trial Master File completeness;
  • Support audit and/or inspection activities;
  • May manage CRO activities;
  • Support Clinical Trial Manager(s). Collaborates with internal team members, Contract Research Organizations, vendors and sites;
  • Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors;
  • Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines;
  • May contribute to process improvement initiatives and departmental projects.

Qualifications:

  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 5 years of relevant clinical trial management experience;
  • Ability and willingness to travel;
  • Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative;
  • Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously;
  • Strong communication and inter-personal skills;
  • Highly responsive and proactive, a team player;
  • Knowledge of CFR and GCP/ICH requirements;
  • Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF);
  • Global Clinical Trial Management experience (preferred);
  • Oncology clinical research experience (preferred).

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© EuroJobsites 2022

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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