Clinical Trials Manager

3 weeks ago


Dublin, Dublin City, Ireland Fastnet - The Talent Group Full time

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Summary:

The Clinical Operations team in Dublin is a pivotal function of the Paediatric Centre of Excellence in Dublin and is responsible for the management and execution of Paediatric Clinical Trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of the products.

The Clinical Trial Manager will be a valued member of the Clinical Operations team in Dublin. They will work with the Clinical Program Manager to manage global clinical trials or regional components of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes.

Responsibilities:

  • Manages global studies and/or regional components of global Phases II-III outsourced studies managed by a Clinical Program Manager.
  • Independently manages all components of a small less complex clinical study.
  • Manages cross functional timelines and maintains the study timelines.
  • Contributes to the development of the study budget.
  • Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
  • Assists in determining the activities to support a project's priorities within a functional area.
  • Drafts and coordinates review of relevant documents including protocols, Informed Consents, Case Report Forms, monitoring plans, Investigator Brochures and Clinical Study Reports.
  • Must be able to understand, interpret and explain protocol requirements to others.
  • Coordinates review of data listings and preparation of interim/final Clinical Study Reports.
  • Contributes to development of RFPs and participates in selection of CROs/vendors.

Requirements:

  • BSc or BA in a relevant scientific discipline or RN qualification.
  • At least five years relevant clinical trial experience in the pharmaceutical industry.
  • Ability to work independently with minimal oversight, identify issues and adapt to changes.
  • Able to examine functional issues from an organisational perspective.
  • Must be able to prioritise multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures.

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Fastnet - The Talent Group
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Dublin 2,
D02 VN24,
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