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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Clinical Trial Manager


Reference:SCAWCM-600073 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

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 Senior 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 and Oncology.


Responsibilities

  • Assist the Senior Clinical Trial Project Manager in managing and overseeing the clinical studies sponsored or financed by the Company
  • Contribute to the creation of the study related documents such us: Monitoring plans, recruitment plans etc
  • Contribute to the creation and maintenance of the study related systems, trackers and correspondent templates and logs and other study related manuals and guidelines
  • Organize, host, and prepare meetings with the selected CROs to review the study progress, site status and monitoring activities. Following the meeting participate in the meeting minutes creation or review, distribution, and filing.
  • Cooperate in creating, maintaining, and reviewing screening and enrolment trackers and logs
  • Cooperate in maintain track of the study activities and tasks and in verifying adherence to study timelines
  • Close oversight on the CRO monitoring activities processes, review of the monitoring visit reports, CRA activity and site documents
  • Participate in development of CRFs and support with the user testing
  • Participate in the development and maintenance of the Inform Consent From and related logs
  • Proactively contribute to identify potential study issues/risks and be able to recommend/implement solutions
  • Manage aspects of the study timelines and report regularly to Senior Clinical Trial Project Manager on clinical study progress and issues
  • Support the administrative department in tracking the study-related invoices and payments
  • Create and maintain study related folders, perform regular QCs on the study documents and file the correspondent documents in the study TMF
  • Provide support to the CRO (either remotely or on-site, as needed) during different types of visits such us pre-selection and initiation visits
  • Occasionally may conduct oversight visits to assess ICH-GCP and protocol compliance and to oversee the CROs in clinical trial monitoring activities and data quality.Travelling will not exceed 20% of total working time
  • Monitor external CRA performance
  • Internal and external project related communication and action items
  • Occasionally perform other duties as assigned

Requirements
  • Third level Science degree, MSc, PhD or other higher Science or healthcare-based degree an advantage
  • At least 3 years of experience as CRA with independent monitoring
  • Experience in using eCRF system
  • Problem solving and negotiating skills
  • Experience in managing outside vendors, e.g., CROs, consultants and other sub-contractors
  • Knowledge and experience of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
  • Ability to recommend and implement innovative process ideas to impact clinical trials management
  • Willingness to perform additional tasks under supervision, which will be part of the internal professional development
  • Soft skills: proactive attitude, flexibility, problem solving, goal orientation, time management and organization
  • Experience in GCP audits is an advantage
  • Experienced in the therapeutic area of GI diseases will be an advantage