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Associate Clinical Trial Manager

Reference:SCAWCM-600073
Location: Dublin
Qualification:Degree
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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Associate Clinical Trial Manager
Our Dublin based client, a specialty pharmaceutical organization, are currently recruiting for an Associate Clinical Trial Manager join their team on a permanent basis. As Associate Clinical Trial Manager you will be working and reporting to the Clinical Trial Project Manager during the following study activities planning, executing, managing and monitoring complex, multinational clinical research projects. As Associate Clinical Trial Manager you will be responsible to manage and oversee various aspects of the clinical trial. The ideal candidate will have experience covering the therapeutic area of Gastrointestinal (GI) diseases.

Responsibilities

  • Draft and contribute to study related documents and regulatory submission
  • Organize and host meetings with the selected CROs to review the study status
  • Proactively contribute to identify potential study issues/risks and be able to recommend/implement solutions
  • Track study recruitment and monitoring visits, review and sign-off monitoring reports, proposing changes when needed
  • Manage study timelines and report regularly to senior management on clinical study progress and issues
  • Maintain oversight of clinical trial data collection.
  • Contribute to the development of study related documents (contracts, ICFs, protocols, IBs, study plans, regulatory submissions for Scientific Advice etc.)
  • Participate in development of CRFs and the design and testing of EDC
  • Travel to clinical trial sites (global locations) and provide support during different types of visits such us pre-selection and initiation by engaging with the sites, discuss recruitment and/or present study timelines
  • Conduct oversight visits to assess, to assess ICH-GCP and protocol compliance and oversee clinical trial monitoring, data quality and CRA performance and identify any risks that might affect the trial conduct
  • Prepare and present metrics reports on study progress and other deliverables to senior management
  • Identify risks and developing issues to senior management
  • Internal and external project related communication
  • Organize and manage internal team meetings, investigator meetings and other trial-specific meetings
  • Review and provide input on study invoices and costs.

Requirements

  • Third level Science degree, MSc, PhD or other higher Science or healthcare-based degree an advantage
  • Experienced in the therapeutic area of GI diseases
  • At least 3 years’ experience CRA with independent monitoring
  • Experience with using eCRF systems
  • Significant experience in managing large international multi-site clinical studies
  • Experience in clinical trial site monitoring
  • Experience of audits an advantage
  • Problem solving and negotiating skills
  • Experience in managing outside vendors, e.g., CROs, consultants and other sub-contractors
  • Strong knowledge and experience of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
  • Must be willing and free to travel to clinical sites in EU, America and worldwide if required
  • Ability to recommend and implement innovative process ideas to impact clinical trials management





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