Global Clinical Trial Manager

Há 3 dias

Buenos Aires, Brasil beBeeProject Tempo inteiro US$100.000 - US$125.000
Senior Project Manager

The Senior Project Manager plays a pivotal role in overseeing the successful management of clinical trials, ensuring all activities and deliverables are completed on time, within budget, and as expected.

A highly effective project manager exhibits leadership to help project teams stay focused on objectives and achieve results. They must have an excellent grasp of GCP and ICH standards, local country regulations, and Microsoft Office suite.

The ideal candidate will have at least 7 years of global clinical project management experience, including management of all project phases from start-up to closure, management of all functional services, vendor management.

  • Experience managing Rheumatology indications studies is essential.
  • Previous experience in managing multisite trials, including Global Phase III projects, is beneficial.
  • The candidate should be looking to position themselves in an environment where they can grow their career alongside a growing organization.
Key Responsibilities:Client Interactions
  • Act as primary contact for the Sponsor.
  • Provide timely and efficient updates on trial progress.
  • Lead client calls effectively.
Project Planning
  • Oversee and actively participate in the preparation of project deliverables such as: study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.
  • Participate in the planning and conduct of the Investigator's Meeting.
  • Ensure that each site has the necessary material to adequately perform the study.
Quality and Risk Management
  • Ensure assigned studies are 'audit ready' at all times.
  • Monitor the quality of study deliverables, (including vendor and SubCRO deliverables) and address issues as they arise.
  • Manage risk and control measures to assure project quality.
  • Analyze discrepancies between planned and actual results.
  • Review and approve responses to quality assurance audits.
Project Budget and Timelines
  • Control the project budget, with particular attention to internal hours allocated to all activities.
  • Identify out-of-scope activities for change orders.
  • Proactively manage operational aspects of the clinical trial, including trial timelines, resources, and vendors.
  • Coordinate tasks and deliverables from all functional departments involved in the project.
  • Communicate effectively with study team members, functional departments, and senior management.
  • Manage and report on recruitment status and highlight initiatives needed to meet recruitment timelines.
Project Team Leadership
  • Lead the core project team, which may include Associate Project Managers, Project Coordinators, Project Assistants.
  • Ensure all team members have adequate training on the project.
  • Work closely with vendors and internal teams to ensure all tasks and deliverables are completed on time, according to plans, and according to applicable standards.

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